Trinity Pharmacy II; Decision and Order, 7304-7336 [2018-03294]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7304-7336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03294]



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Vol. 83

Tuesday,

No. 34

February 20, 2018

Part II





 Department of Justice





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Drug Enforcement Administration





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Trinity Pharmacy II; Decision and Order; Notice

Federal Register / Vol. 83 , No. 34 / Tuesday, February 20, 2018 / 
Notices

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-28]


Trinity Pharmacy II; Decision and Order

    On July 10, 2015, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Trinity Pharmacy II, Inc. (hereinafter ``Trinity II'' or 
Respondent), which proposed the revocation of its DEA Certificate of 
Registration FT0531586, pursuant to which Trinity II is authorized to 
dispense controlled substances in schedules II through V as a retail 
pharmacy, at the registered location of 1474 South Belcher Road, 
Clearwater, Florida. Administrative Law Judge Exhibit (ALJ Ex.) 1b, at 
1. As grounds for the proposed action, the Show Cause Order alleged 
that Respondent's ``continued registration is inconsistent with the 
public interest.'' Id. (citing 21 U.S.C. 823(f) and 824(a)(4)).
    More specifically, the Show Cause Order set forth seven independent 
reasons why Respondent's registration should be revoked. Id. at 2-17. 
First, the Show Cause Order charged that, between February 2012 and 
February 2014, Trinity II ``committed acts as would render its 
continued registration inconsistent with the public interest'' pursuant 
to 21 U.S.C. 824(a)(4) because Respondent (1) ``failed to comply with 
applicable federal and Florida state laws relating to controlled 
substances'' (citing 21 U.S.C. 823(f)(4)) and (2) ``exhibited negative 
experience in its dispensing of controlled substances'' (citing 21 
U.S.C. 823(f)(2)). Id. at 1, 2. During this period, the Order alleged 
that pharmacists at Trinity II ``filled [prescriptions for] and 
dispensed controlled substances on numerous occasions outside the usual 
course of pharmacy practice and in contravention of their corresponding 
responsibility,'' and that such pharmacists did so even when such 
prescriptions ``contained one or more `red flags' [f]or drug abuse or 
diversion without resolving the red flag(s) and, in certain 
circumstances, w[h]ere the red flags were unresolvable.'' Id. at 2-3 
(citing Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 
FR 62316, 62321-22 (2012)).
    The Show Cause Order listed six red flags of diversion which 
Respondent's pharmacists allegedly failed to resolve before dispensing 
prescriptions, including: (1) ``[e]arly [f]ills,'' in which nine 
customers sought ``to fill a new controlled substance prescription or 
refill an existing controlled substance prescription well before the 
customer should have exhausted the supply . . . obtained from the 
previous prescription;'' (2) unusual distance traveled, in which six 
customers ``present[ed] a prescription bearing an address for the 
customer and doctor showing that the customer had travelled an unusual 
or suspicious route to obtain their prescriptions and fill them at 
Trinity II;'' (3) ``[c]ocktail prescriptions,'' in which eight 
customers ``present[ed] multiple prescriptions that provided the 
individual with the cocktail of an opioid, a benzodiazepine, and a 
muscle relaxer;'' (4) ``[d]uplicative drug therapies,'' whereby eight 
customers ``present[ed] multiple prescriptions which provided the 
person duplicative drug treatment;'' (5) ``[t]wo prescriptions for the 
same drug,'' in which 10 ``customers present[ed] two prescriptions for 
the same drug on the same date;'' and (6) ``pattern prescribing,'' or a 
lack of individualized drug therapy, in which two sets of ``two 
individuals present[ed] prescriptions on the same day for the same 
drugs that were issued by the same prescriber.'' Id. at 3-14.
    Second, the Show Cause Order charged Trinity II with violating 
federal law when it dispensed ``a Schedule II controlled substance 
outside the usual course of professional practice . . . and in 
contravention of its corresponding responsibility . . . [when it] 
filled a prescription for customer D.G.'' on November 8, 2013 for ``7 
patches of Duragesic 50 mcg/hr (fentanyl).'' Id. at 14 (citing 21 CFR 
1306.04(a), 1306.06). The Order alleged that Trinity II filled this 
prescription even though D.G. had 12 days left on a prescription issued 
by a different doctor and filled by Trinity II on October 21, 2013 for 
a ``thirty-day supply'' of fentanyl patches that should have lasted 
D.G. until November 20, 2013. Id. The Order further alleged that when 
Trinity II filled the second prescription for D.G. 12 days early, 
Trinity II ``ignored the bright red flags that D.G. was abusing and/or 
diverting the fentanyl by doctor-shopping and seeking an early fill of 
fentanyl.'' Id.
    Third and fourth, the Show Cause Order charged that Trinity II 
violated federal law when it twice dispensed to D.G. ``a Schedule II 
controlled substance without a valid prescription,'' ``outside the 
usual course of professional practice,'' ``and in contravention of its 
corresponding responsibility.'' Id. at 14, 15 (citing 21 U.S.C. 829; 21 
CFR 1306.04(a), 1306.06, 1306.11(a)). In the third charge, the Order 
alleged that D.G. presented Trinity II with a prescription dated 
November 15, 2013 ``for 15 patches of Duragesic 50 mcg/hr (fentanyl), a 
Schedule II controlled substance,'' that also contained the following 
instruction from the prescribing practitioner: ``NO EXCEPTIONS DO NOT 
FILL UNTIL 12-06-2013.'' Id. at 14. The Order alleged that Trinity II 
nevertheless filled the prescription on November 20, 2013. Id. In the 
fourth charge, the Order alleged that D.G. presented Trinity II with a 
prescription in December 2013, also ``for 15 patches of Duragesic 50 
mcg/hr (fentanyl), a Schedule II controlled substance,'' that also 
contained the following instruction from the prescribing practitioner: 
``NO EXCEPTIONS DO NOT FILL UNTIL 1-05-2014.'' Id. at 15. The Order 
alleged that Trinity II nevertheless filled the prescription on 
December 18, 2013. Id. As a result, and with respect to each of these 
charges, the Order alleged that Trinity II ``filled and dispensed this 
controlled substance to D.G. approximately two weeks before the 
prescriber had authorized it to do so, and, thus, before the 
prescription was valid for filling.'' Id. at 15.
    Fifth, the Show Cause Order charged that, on eight occasions 
between July 12, 2012 and January 25, 2013, Trinity II violated federal 
law when it dispensed to J.T. ``a Schedule II controlled substance 
without a valid prescription'' and ``outside the usual course of 
professional practice.'' Id. (citing 21 U.S.C. 829; 21 CFR 1306.06, 
1306.11(a)). Specifically, the Order alleged that Trinity II dispensed 
to J.T. ``a morphine sulfate solution'' ``that was five times more 
potent than the doctor had prescribed, and instructed J.T. to take a 
dosage amount that would result in him receiving five times the 
amount'' prescribed. Id. The Order further alleged that such 
prescriptions ``placed the health and safety of J.T. at risk and, thus, 
engaged in conduct that may have threatened the public health and 
safety'' pursuant to 21 U.S.C. 823(f)(5). Id. at 16.
    Sixth, the Show Cause Order charged that ``Trinity II unlawfully 
distributed controlled substances in violation of federal and Florida 
state law by utilizing non-pharmacists to fill controlled substances 
prescriptions on numerous occasions between February, 2012 and 
February, 2014.'' Id. The Order alleged that when Trinity II allowed 
its non-pharmacist ``pharmacy interns'' to fill a prescription, it was 
not filled by a pharmacist ``acting in the usual course of his 
professional practice,'' pursuant to 21 CFR 1306.06, nor were Trinity 
II's pharmacists properly exercising their ``corresponding 
responsibility'' under 21 CFR 1306.04(a). Id. The Order further

[[Page 7305]]

alleged that such prescriptions violated Florida law's requirement that 
``[a] pharmacist, in good faith and in the course of professional 
practice only, may dispense controlled substances.'' Id. (citing Fla. 
Stat., Ch. 893.04(1)).
    Seventh, and lastly, the Show Cause Order charged that, ``if 
Trinity II's pharmacists in fact filled the prescriptions referenced in 
[the sixth charge], then Trinity II violated federal and Florida state 
law on numerous occasions between February 2012 and February 2014 by 
failing to maintain accurate records of the controlled substances it 
dispensed because they do not identify a pharmacist who filled the 
controlled substance prescription.'' Id. at 16-17 (citing 21 CFR 
1304.22(c), 1306.06; Fla. Stat., Ch. 893.04(1)(c)(6)).
    In a letter from its counsel dated August 12, 2015, Trinity II 
acknowledged receipt of the Show Cause Order and requested a hearing on 
the allegations. ALJ Ex. 2b. The matter was placed on the docket of the 
Office of Administrative Law Judges and assigned to Chief 
Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ), who 
proceeded to conduct pre-hearing proceedings as follows.\1\
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    \1\ Respondent raised no objection to the adequacy of service.
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    On August 13, 2015, the CALJ issued an Order for Prehearing 
Statements (hereinafter, Prehearing Order). See ALJ Ex. 3b. In the 
Prehearing Order, the CALJ directed the Government to file its 
Prehearing Statement no later than 2 p.m. on August 24, 2015, 
Respondent to file its Prehearing Statement no later than 2 p.m. on 
September 8, 2015, and scheduled a Prehearing Conference for 1:30 p.m. 
on September 9, 2015. Id. at 1-2. The Order also directed the parties 
to provide the ``[n]ames and current addresses of all witnesses whose 
testimony is to be presented,'' and that if the Respondent's corporate 
representative intends to testify, the representative ``must be listed 
as a witness, and a summary of his/her testimony as described below 
must be provided.'' Id. at 2. The CALJ's Order provided the following 
instruction regarding the summaries of testimony:

    Brief summary of the testimony of each witness (counsel for the 
Government to indicate clearly each and every act, omission or 
occurrence upon which it relies in seeking to revoke the 
Respondent's [Certificate of Registration]; counsel for Respondent 
to indicate clearly each and every matter as to which Respondent 
intends to introduce evidence in opposition). The summaries are to 
state what the testimony will be rather than merely listing the 
areas to be covered. The parties are reminded that testimony not 
disclosed in the prehearing statements or pursuant to subsequent 
rulings is likely to be excluded at the hearing.

Id. The Order further emphasized that ``[f]ailure to timely file a 
prehearing statement that complies with the directions provided above 
may be considered a waiver of hearing and an implied withdrawal of a 
request for hearing.'' Id. at 3.
    On August 21, 2015, the Government filed its Prehearing Statement. 
ALJ Ex. 4b. On August 24, 2015, the CALJ issued an ``Order Rescheduling 
Prehearing Conference'' moving the prehearing conference up to 10:30 
a.m. on September 3, 2015 in light of Respondent's counsel's August 20, 
2015 notice of a conflict with the scheduled hearing on October 26, 
2015. ALJ Ex. 8b at 1.\2\ Although this Order stated that ``[a]ll other 
dates specified in the [Prehearing Order], including the filing date 
for the Respondent's Prehearing Statement, remain in effect,'' id. at 1 
n.1, the CALJ (through his staff) later requested that Respondent file 
its Prehearing Statement early. ALJ Ex. 10 at 1 n.1 (``Upon my 
realization that the status conference was now scheduled several days 
prior to the date that the Respondents' prehearing statements were due 
under the terms of the [Prehearing Order], chambers staff (at my 
direction) reached out to Respondents' counsel and requested (but not 
directed) that, if it was possible to do so, their prehearing 
statements be filed prior to the commencement of the now-rescheduled 
Status Conference . . . with the assurance that (as is customary) both 
sides would be permitted to file supplemental prehearing statements'').
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    \2\ According to the CALJ, ``[t]he hearing commencement date 
[was] continued on multiple occasions at the Respondents' request.'' 
ALJ Ex. 34, at 1 n.1. The hearing was ultimately noticed to begin on 
January 4, 2016. ALJ Ex. 27.
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    Per the CALJ's request, Trinity II filed its ``Preliminary 
Prehearing Statement'' on September 3, 2015. ALJ Ex. 9b. Trinity II 
proposed to call 77 witnesses in addition to ``[a]ny and all witnesses 
identified in the Government's Prehearing Statement.'' Id. at 3-7. 
Trinity II then provided a ``Summary of Anticipated Testimony'' for 
nine of these witnesses, all of whom were the owners or employees of 
Trinity II. Id. at 7-14. Trinity II stated that it anticipated calling 
an expert witness but had not yet identified one ``given the 
preliminary nature of this statement.'' Id. at 14. Trinity II offered 
an identical one-sentence summary of the testimony for each of 39 
``patients,'' and a separate identical one-sentence summary of the 
testimony for each of 32 ``prescribing physicians.'' Id. at 14-15. 
Trinity II also proposed as documents for the hearing copies of ``all 
prescriptions, patient profiles and related documents maintained by 
Trinity Pharmacy II in connection with each patient described in the 
[Show Cause Order].'' Id. at 16.
    On September 3, 2015, the CALJ conducted an on-the-record 
prehearing conference. During that conference, the CALJ noted the 
Government's motion to consolidate the hearings for Trinity II and 
Trinity Pharmacy I \3\ (hereinafter, collectively, Respondents) and 
asked Respondents' counsel to file something confirming that Trinity I 
and Trinity II waive any potential conflict in having him represent 
them both at a consolidated hearing. Transcript (``Tr.'') 5; ALJ Ex. 10 
n.4 (same).\4\ The CALJ also noted during the proceedings that the 
Government was seeking an ``Order of Protection'' to limit disclosure 
of personally identifiable information of patients and confirmed that 
Respondent had no objection to such an order. Tr. 55-56. Lastly, the 
CALJ accepted Respondents' counsel's representation that neither 
Trinity I nor Trinity II were the subject of pending state 
administrative cases or ``criminal parallel proceedings.'' Id. at 63.
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    \3\ Trinity Pharmacy (``Trinity I''), located in Seminole, 
Florida, was served with a separate July 10, 2015 Order to Show 
Cause by the Government. ALJ Ex. 1a. Although the CALJ eventually 
ordered the consolidation of the evidentiary hearings for Trinity I 
and Trinity II, see ALJ Ex. 10 at 2, the CALJ wrote separate 
recommendations regarding each Respondent, and I therefore have 
written a separate Order regarding the disposition of the Show Cause 
Order directed at Trinity I.
    \4\ On November 13, 2017, Mr. Michael Stanton filed a ``Notice 
of Appearance on Behalf of Respondents'' in which he entered ``an 
appearance as co-counsel for Respondents, Trinity Pharmacy I and 
Trinity Pharmacy II, along with Dale Sisco of Sisco Law.'' ALJ Ex. 
35b, at 2. Although both counsel maintained that they represented 
both Respondents, at the evidentiary hearing, Mr. Sisco stated that 
``[f]or the purposes of this hearing, I will be representing Trinity 
I and questioning witnesses on behalf of that pharmacy,'' and Mr. 
Stanton stated that ``for purposes of this hearing and to avoid any 
duplication, I will be handling the objections and the questioning 
on behalf of Trinity II.'' Tr. 83-84.
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    On September 4, 2015, the CALJ issued a ``Consolidation Order, 
Prehearing Ruling, and Protective Order'' (hereinafter ``Consolidation 
Order''). ALJ Ex. 10 at 2. In this Order, the CALJ granted the 
Government's request for the aforementioned protective order and the 
Government's motion to consolidate the hearings, and the CALJ directed 
all parties to file a consolidated exhibit and witness list by October 
16, 2015. Id. at 2, 9-11. The Order noted that the parties would be 
able to cross-examine the others' witnesses and stated that the 
``parties are also reminded that testimony not

[[Page 7306]]

summarized in prehearing statements, or supplements thereto, may be 
excluded at the hearing.'' Id. at 4. The Order also directed the 
parties to serve each other with all documents it intends to identify 
as exhibits no later than September 11, 2015, and directed Respondents 
to supply the identity and curriculum vitae of their proposed expert 
witness by September 18, 2015. Id. at 4, 8. The Order further directed 
the parties to file supplemental prehearing statements and any 
additional exhibits, as well as any motions seeking relief, by 2 p.m. 
on October 16, 2015, and any responsive filings by 2 p.m. on October 
23, 2015. Id. at 8. Finally, the Order reminded the parties that 
``documents not noticed in prehearing statements, or supplements 
thereto, or not timely supplied to the opposing party may (and likely 
will) be excluded at the hearing.'' Id. at 4.
    Although the Prehearing Order had directed Trinity II to supply a 
compliant prehearing statement by September 8, 2015, ALJ Ex. 3b at 1, 
and the Order Rescheduling Prehearing Conference iterated that Trinity 
II's prehearing statement filing deadline remained the same, ALJ Ex. 8b 
at 1 n.1, Trinity II failed to do so. On September 24, 2015, the 
Government filed a Motion to Compel Respondents' Compliance with the 
Prehearing Order and the Consolidation Order and a Motion Requesting a 
New Supplemental Prehearing Statement and Motion Deadline. ALJ Exs. 
11a, 11b.
    On September 28, 2015, Respondents filed their response. ALJ Ex. 
13. On the same day, the CALJ issued an Order that generally denied the 
Government's motions and stated that honoring the CALJ's request for an 
earlier prehearing statement may have caused Respondents to have had 
the:

mistaken impression that compliant prehearing statements were no 
longer required until the filing of supplemental prehearing 
statements. To alleviate any remaining misunderstanding in this 
regard and to afford the Respondents the time and ability to file 
both a fulsome prehearing statement and a supplemental prehearing 
statement, it is ORDERED that Respondents are to file prehearing 
statements that comply with the terms of the [Prehearing Statement] 
no later than 2 p.m. on October 5, 2015.

ALJ Ex. 14, at 3-4.
    On October 5, 2015, Trinity II filed its Prehearing Statement. ALJ 
Ex. 15b. Trinity II provided the names and address of 79 proposed 
witnesses, in addition to ``[a]ny and all witnesses identified in the 
Government's Prehearing Statement.'' Id. at 4-7. Trinity II also 
provided a ``Summary of Anticipated Testimony'' for nine witnesses who 
were either owners or employees of Trinity II, a putative expert, and 
short but similar descriptions of testimony for 39 patients and 32 
prescribing physicians. Id. at 7-54.\5\ The Prehearing Statement also 
identified 70 documents ``intended to be used at the consolidated 
hearing regarding both Trinity Pharmacy I and Trinity Pharmacy II.'' 
Id. at 55-57, 55 n.2. On October 15, 2015, Respondents filed a 
``Consolidated Witness and Exhibit List'' that listed 133 witnesses, in 
addition to ``[a]ny and all witnesses identified in the Government's 
Prehearing Statement,'' 69 exhibits of ``[d]ocuments and information 
related to'' various individuals, and one exhibit that would be the CV 
of their putative expert. ALJ Ex. 15e.
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    \5\ For example, for patient S.B., Trinity II stated that it 
anticipated her testimony to be as follows:
    [S.B.] was a patient whose prescriptions are identified in the 
various categories of allegations contained in the July 10, 2015 
Order to Show Cause issued to Trinity Pharmacy II. It is anticipated 
that [S.B.] will testify regarding the inquiry done by the 
pharmacists and the staff at Trinity II regarding verification of 
her prescriptions and for the resolution of any potential red flags. 
[S.B.] will further confirm the information obtained from her by 
Trinity Pharmacy II prior to any prescription being dispensed, 
including but not limited to explanations for any significant 
distances traveled, the type of payment they made for the 
prescriptions, the circumstances of any refills and physician 
authorization for same.
    ALJ Ex. 15b, at 29. The proposed testimony of most of the other 
patients used similar language. See id. at 27-43. Likewise, the 
physician summaries used language similar or identical to the 
following example:
    [J.M.], M.D. was a prescribing physician for one or more of the 
patients who tendered prescriptions to Trinity Pharmacy II. [J.M.], 
M.D. will confirm the prescriptions he authorized were for a 
legitimate medical purpose and issued in the usual course of 
professional practice to patients that were known to him. Further, 
[J.M.], M.D. will describe his interaction with the pharmacists and 
staff at Trinity Pharmacy II, the authorization of refills or early 
fills, if any, and explanations for any duplicative drug therapy, 
combinations of medications or alleged ``drug cocktails.''
    Id. at 45.
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    On October 16, 2015, the Government filed its ``Consolidated 
Supplemental Prehearing Statement.'' ALJ Ex. 16a. In this filing, the 
Government proposed two new witnesses, provided a summary of their 
testimony, and provided additional summaries for the testimony of the 
fact and expert witness identified in the Government's original 
Prehearing Statement. Id. at 6-10. Lastly, the Government supplemented 
its list of proposed Government exhibits with a list of additional 
documents that it intended to introduce as exhibits at the hearing. Id. 
at 10-12. The Government also filed its consolidated witness list and 
exhibit list. ALJ Exs. 16b, 16c.
    Trinity II did not file a supplemental prehearing statement or any 
other prehearing statement by October 16, 2015 as required by the 
CALJ's Consolidation Order. As a result, the Government filed a 
``Motion in Limine to Exclude Certain Testimony.'' ALJ Ex. 28. In its 
Motion, the Government contended that Respondents had failed in their 
prehearing statements to follow the requirements set forth in the 
CALJ's prehearing orders; namely, to ``state what the testimony will be 
rather than merely listing areas to be covered'' for each proposed 
witness.'' Id. at 2 (internal citations omitted). For example, the 
Government noted that Respondents proposed 69 witnesses identified as 
patients and that ``nearly every single patient of the sixty-nine 
listed by the Respondents is expected to testify identically.'' Id. at 
4. The Government contended that, not only did the proposed patient 
``testimony fail to make clear exactly what `information' each patient 
will `confirm,' thus preventing the Government from determining what 
specific defense(s) Respondents allege; the [proposed] testimony also 
fails to provide any basis upon which the Government can evaluate 
[whether] such information is even relevant or material to this case.'' 
Id. at 4-5. Such proposed testimony, the Government argued, ``is 
nothing more than `merely areas to be covered,' rather than any 
substantive recitation of `what the testimony will be,' '' as the 
prehearing orders required, ``offering no facts that, if proven, would 
rebut the Government's prima facie case or offer credible evidence in 
mitigation. Id. Finally, the Government argued that ``it is unclear 
from the Respondents' Prehearing Statements how the purported testimony 
of these various patients related to each of the dispensing events 
charged in the [Show Cause Orders], and how it affected the 
pharmacist's compliance with the standard of care and exercise of his 
corresponding responsibility in each charged instance.'' Id.
    With respect to the prescribing physicians that Respondents had 
proposed as witnesses, the Government noted that Respondents ``intend 
to call fifty-nine doctors as witnesses, who, again, will each testify 
identically. . . . Other than to blithely forecast that the physicians 
will approve their own prescriptions, Respondent provides no facts 
which, if proven, would rebut the Government's prima facie case.'' Id. 
at 6. This too, the Government contended, violated the requirement of 
the prehearing orders that the parties set forth ``what the testimony 
will be''

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rather than ``areas to be covered.'' Id. The Government argued that the 
summary of the physicians' proposed testimony failed to disclose 
sufficient facts to allow the Government to determine what specific 
defenses Respondents allege, nor provide any basis upon which the 
Government can evaluate how such information is relevant to the charges 
in the Show Cause Order. Id. at 6-7.
    In its Motion, the Government also challenged the adequacy of 
Respondents' disclosure of the proposed testimony of its owners and 
employees, contending that it too set forth ``a generalized statement 
of `areas to be covered' '' rather than ``a summary of `what the 
testimony will be' for each witness.'' Id. at 9. These generalized 
statements, the Government contended, failed ``to reveal the specific 
`actions' each employee purportedly is going to `describe' '' or ``to 
provide the Government (or the ALJ) any information upon which it can 
discern the relevance and materiality of the `actions' to the issues to 
be litigated in this case.'' Id. Although Respondents stated in their 
prehearing statements that certain employees would testify to describe 
the ``process'' Trinity II used ``to verify prescriptions and resolve 
concerns, if any, regarding the validity of those prescriptions,'' the 
Government argued that the statements ``fail[ed] to provide any 
information about the `process' '' employed to verify prescriptions and 
resolve concerns. Id. at 9-10. Similarly, the Government observed that 
Respondents' offer of testimony from employees who would provide ``a 
description and demonstration of the computer software used by the 
pharmacy in this process'' was not matched by a proposed ``exhibit 
containing each pharmacy's computer software that each witness 
purportedly would demonstrate for the court.'' Id. And while 
Respondents proposed its co-owners would testify about their knowledge 
of both their customers' medical conditions and the treating physicians 
efforts to ``resolve[ ] any concerns,'' the Government further alleged 
that Respondents failed to disclose ``each customer's medical condition 
. . . , how it related to each dispensing activity, or how and when 
each pharmacy purportedly became `aware' of it.'' Id. at 11.
    In its Motion, the Government also sought to preclude Respondents' 
proposed expert, Mr. Sam Badawi, from rendering an opinion concerning 
whether the prescriptions referenced in the Show Cause Orders ``were 
filled in compliance with federal and/or state law requirements.'' Id. 
at 14. Specifically, the Government alleged that Respondents failed to 
give the Government ``notice [of] a proposed opinion from Mr. Badawi as 
to the lawfulness of each prescription alleged in each'' Show Cause 
Order. Id. at 17 (``Respondents have had multiple opportunities to 
provide a compliant disclosure, yet have repeatedly failed to do 
so.'').
    As a result of these alleged deficiencies, the Government requested 
that the CALJ exclude ``the non-conforming testimony'' set forth in its 
Motion because Respondents had only provided ``vague summaries of areas 
to be covered by the Respondent's witnesses'' that unduly prejudiced 
the Government. Id. at 18-19 (``Agency precedent favors exclusion of 
evidence when the names of witnesses and `an adequate summary of their 
testimony' has `not been previously disclosed as required by the ALJ's 
Order for Pre-Hearing Statements.' '') (citing East Main Street 
Pharmacy, 75 FR 66149, 66150 (2010)).
    On November 5, 2015, the CALJ issued an ``Order Granting the 
Government's Unopposed Motion in Limine to Exclude Certain Testimony.'' 
ALJ Ex. 29. After noting the Government's timely filed Motion and that 
Respondents' deadline to file a responsive pleading was October 23, 
2015, the CALJ noted:

    Respondents never filed a response. Not even a late or 
unpersuasive response. Nothing. The language of the [Prehearing 
Order] about the nature of the required notice proffers is clear and 
unambiguous; yet, notwithstanding multiple opportunities to do so, 
the Respondents have elected not to comply. The [Prehearing 
Statement] plainly states that ``testimony not disclosed in the 
prehearing statements or pursuant to subsequent rulings is likely to 
be excluded at the hearing.''

ALJ Ex. 29, at 2. Although the CALJ posited that Respondents' repeated 
failure to comply with his orders could constitute a waiver of a 
hearing request, the CALJ also noted that the Government ``does not 
seek (as it could have) the draconian remedy of hearing waiver, but 
asks for the lesser sanction of preemptive exclusion of a limited 
subset of the noticed evidence,'' and the CALJ deemed the Motion 
unopposed and granted it. Id. at 3-4. Specifically, the CALJ's Order 
precluded Respondents from offering the following:

    1. ``testimony from sixty-nine patients identified as proposed 
witnesses;''
    2. ``testimony from fifty-nine physicians identified as proposed 
witnesses;''
    3. ``testimony from proposed witness Nina Ghobrial;''
    4. ``evidence regarding the actions of DEA personnel and the 
cooperation of pharmacy staff during the Administrative Inspection 
of both pharmacies;''
    5. ``evidence regarding the process the pharmacies used to 
verify prescriptions and resolve concerns, including a description 
and demonstration of the computer software utilized;''
    6. ``evidence regarding the medical condition of patients who 
received early refills;''
    7. ``evidence of the pharmacy's knowledge of cocktail 
prescription and duplicative drug therapy patients, their medical 
condition, and their treating physicians;''
    8. ``evidence regarding circumstances surrounding an early fill 
for patient T.B.;''
    9. ``evidence regarding circumstances surrounding an early fill 
for patient C.F.;''
    10. ``evidence regarding information that Trinity I allegedly 
possessed relating to an early fill for patient J.K.;''
    11. ``evidence regarding circumstances surrounding an early fill 
for patient G.S.;''
    12. ``evidence regarding distances traveled by patients who 
either commuted, lived, or worked close to both pharmacies;'' and
    13. ``evidence from the Respondents' proposed expert, Sam 
Badawi, regarding the lawful or unlawful nature of the numerous 
prescriptions referenced in each of the [Show Cause Orders].''

Id. at 3-4 (citing ALJ Ex. 28 at 4-18).
    Over a month later, on December 7, 2015, Respondents filed their 
``Motion for Reconsideration on Behalf of Respondents'' in which they 
``request[ed] an order reconsidering [the CALJ's] order granting the 
Government's motion in limine, and allowing Respondents to provide [the 
CALJ] with the necessary evidence needed for [the] final 
determination.'' ALJ Ex. 32, at 1. Respondents stated that ``due 
process requires that Respondents be entitled to present testimony from 
its witnesses, which were properly disclosed.'' Id. at 3. Respondents 
also stated that they ``recognize that the physician and patient 
disclosures lack particularity'' because ``Respondents cannot exercise 
sufficient control over these witnesses without first having them under 
subpoena to provide more detail.'' Id. at 3 n.1. Respondents added that 
``[n]either the Government nor the Respondents should fear the Court 
learning the full truth . . . even if there may not be a way for any 
party to control that message before the hearing.'' Id. Respondents 
also contended that ``those same deficiencies . . . do not apply'' to 
their employee, expert, and owner witness disclosures. Id. Indeed, 
Respondents argued that ``it is disingenuous for the Government to 
alleged [sic] that the [expert witness] disclosure fails to provide 
adequate notice to allow it to prepare for a cross-examination when its 
prehearing statements provide a comparable

[[Page 7308]]

opportunity for notice to Respondents.'' Id at 4-5. Respondents contend 
that their ``representatives and pharmacist'' witness disclosures were 
``similarly robust and detailed,'' and that their ``remaining pharmacy 
employees['] [witness] disclosures are brief.'' Id. at 5. Finally, 
Respondents claim that ``an intermediate remedial order requiring 
supplementation or a limit to the testimony would have been more 
appropriate than granting the motion in limine in its entirety.'' Id.
    The Government filed its ``Opposition to Respondents' Motion for 
Reconsideration'' on December 10, 2015. ALJ Ex. 33. In its Opposition, 
the Government argued that, as a threshold matter, ``Respondents have 
not even provided a basis--not to mention a plausible one that would 
demonstrate good cause--upon which to reconsider the decision.'' Id. at 
4 (Respondents gave no ``explanation or justification for their failure 
to file a timely response on October 23, 2015.''). Id. ``Respondents['] 
Reconsideration Motion is a request for the ALJ to reconsider his 
decision on a Motion that they did not see fit to oppose in the first 
place, and have not seen/did not see fit [ ] to oppose for the past 
month.'' Id. In response to Respondents' concession that their patient 
and physician witness disclosures lacked particularity because they 
lacked subpoena authority, the Government contended that ``Respondents 
are unable to explain why they needed a subpoena to talk to their own 
customers and the physicians about prescriptions Respondents contend 
were lawfully issued. Nor do Respondents indicate that they attempted 
to contact these individuals and were rebuffed.'' Id. And finally, with 
respect to Respondents' Due Process argument, the Government noted 
that, ``despite hav[ing] been given multiple opportunities to correct 
their mistakes and provide the Government the requisite notice it was 
due,'' Respondents were attempting ``to shift the blame'' by ``now 
claiming that the ALJ is denying them a fair hearing.'' Id. at 4-5.
    On December 10, 2015, the CALJ issued his ``Order Denying the 
Respondents' Motion for Reconsideration.'' ALJ Ex. 34. In this Order, 
the CALJ noted that Respondents ``filed neither a response to the 
Government's motion [in Limine] nor a motion for an extension of time 
to do so. Indeed, the Respondents filed nothing.'' Id. at 1. The CALJ 
also observed that he waited an additional 13 ``days after the 
responsive filing deadline'' before issuing his Order granting the 
Government's Motion in Limine, ``perhaps hoping in vain for even a late 
response.'' Id. Indeed, the CALJ emphasized that Respondents did not 
file their Motion for Reconsideration until ``over forty-five days from 
the date their motion response was due and less than a month prior to 
the . . . commencement of the hearing.'' Id. (Respondents ``do[ ] not 
even mention the fact that no response was filed, as if it never 
happened''). The CALJ noted that Respondents asked for another order to 
give Respondents additional opportunities to cure any alleged 
deficiencies in their disclosures ``[u]nder th[e] theory[ ] this new, 
additional order would somehow carry more force and would result in 
compliance where the other orders had failed. Enough.'' Id. at 2. The 
CALJ found that Respondents ``have tendered no explanation for their 
failure to answer the Government's motion and no basis upon which to 
base good cause for reconsideration, even if such relief was 
warranted--which it is not.'' Id. Accordingly, the CALJ denied 
Respondents' reconsideration motion. Id. at 3.\6\
---------------------------------------------------------------------------

    \6\ On December 11, 2015, the CALJ granted Respondents' requests 
for subpoenas for their pharmacy employees and denied Respondents' 
requests vis-[agrave]-vis their proposed practitioner witnesses 
pursuant to the Order granting the Government's Motion in Limine. 
ALJ Ex. 36.
---------------------------------------------------------------------------

    The CALJ conducted an evidentiary hearing on January 4-8, 2016, in 
Arlington, Virginia, and on January 11-12, 2016, in Tampa, Florida. See 
Recommended Decision (R.D.), at 2. At the hearing, both parties 
elicited testimony from multiple witnesses, and the Government 
submitted various exhibits. Following the hearing, on February 26, 
2016, both parties filed briefs containing their proposed findings of 
fact, conclusions of law, and argument. ALJ Exs. 40a, 41. On February 
29, 2016, the CALJ issued an ``Order Regarding the Exhibit (and 
Appended Attachments) Included with the Government's Closing Brief'' 
noting that the Government's proposed findings of fact and conclusions 
of law had attached a declaration from the Government's lead attorney 
as well as six attachments thereto and asking Respondents if they 
intended ``to take a position on the Agency's consideration of factual 
matters set forth'' in the declaration and attachments. ALJ Ex. 40b, at 
1. Respondents filed joint objections to the declaration and 
attachments. ALJ Ex. 40c. On March 4, 2016, the CALJ issued an Order 
sustaining Respondents' objections, ruling that the declaration and 
attachments are ``EXCLUDED from the record, and will not be considered 
as evidence in these matters'' and ``will not be considered by this 
tribunal in its recommended decision.'' ALJ Ex. 40d, at 1 & n.3.
    On May 12, 2016, the CALJ issued and served his Recommended 
Decision. Specifically, the CALJ found that the Government had 
``supplied sufficient evidence to make out a prima facie case that 
maintaining the Respondent's [DEA Registration] would be contrary to 
the requirements of 21 U.S.C. 823 and 824'' based on the third, fourth, 
and fifth charges set forth in the Show Cause Order. R.D. at 51. The 
CALJ further held that the testimony of the Government's expert was 
``insufficiently reliable to establish a breach of the Respondent 
pharmacy's corresponding responsibility regarding the dispensing of 
controlled substances'' pursuant to 21 CFR 1306.04 as set forth in the 
first two charges of the Order. Id. at 43.\7\ Although the CALJ 
acknowledged that his decision not ``to rely on the Government's expert 
witness dramatically pared down the number of noticed transgressions 
that could be and were established by a preponderance'' of the 
evidence, the CALJ concluded that ``the evidence demonstrates a culture 
in the Respondent pharmacy of ignoring regulations deemed inconvenient 
. . . this pharmacy is dangerous, and the owners have given not even 
the smallest indication to the Agency that there is any inclination to 
change.'' Id. at 53-54. The CALJ also concluded that the Respondent 
``fail[ed] to accept responsibility.'' Id. at 54. Thus, the CALJ 
recommended that I revoke Respondent's registration and deny any 
pending applications for renewal. Id. On June 2, 2016, the Government 
and Respondents each filed Exceptions to the CALJ's Recommended 
Decision. Thereafter, the record was forwarded to me for final agency 
action.
---------------------------------------------------------------------------

    \7\ The CALJ also found that the Government failed to sustain 
the sixth and seventh charges of the Show Cause Order related to 
prescriptions filled by pharmacy interns. R.D. at 43-46.
---------------------------------------------------------------------------

    Having considered the record in its entirety, including the 
parties' Exceptions (which I discuss throughout this decision), I do 
agree with the CALJ's conclusions that the Government sustained the 
Order's third, fourth and fifth charges. I also agree with the CALJ's 
conclusions that the Government failed to sustain the Order's second, 
sixth and seventh charges. And I further agree with his legal 
conclusion that Trinity II has failed to accept responsibility for the 
misconduct which has been proven on the record of the proceeding. 
However, I disagree with the CALJ's conclusion that the

[[Page 7309]]

Government did not prove the first charge of the Show Cause Order 
alleging that Trinity II violated its corresponding responsibility 
pursuant to 21 CFR 1306.04(a).\8\ Accordingly, I agree with the ALJ's 
ultimate conclusion that Trinity II has committed acts which render its 
continued registration inconsistent with the public interest and will 
adopt his recommendation that I revoke Trinity II's registration and 
deny any pending applications. As the ultimate fact finder, I make the 
following findings of fact.
---------------------------------------------------------------------------

    \8\ Although I do not rely on the Government expert's testimony 
in making my ruling, as set forth infra, I also disagree with the 
CALJ's conclusion that the Government's expert was not reliable.
---------------------------------------------------------------------------

Findings of Fact

    Trinity II is the holder of DEA Certificate of Registration 
FT0531586, pursuant to which it is authorized to dispense controlled 
substances in schedules II through V, as a retail pharmacy, at the 
registered location of 1474 Belcher Rd., Clearwater, Florida. 
Government Exhibit (``GX'') 34; Tr. 120, 685-86. Respondent's 
registration was due to expire on November 16, 2016, R.D. at 3; 
however, having reviewed the Agency's registration records, I take 
official notice that on October 3, 2016, Trinity II submitted a renewal 
application.\9\ Because Trinity II has timely submitted a renewal 
application, I find that Trinity II's registration has remained in 
effect pending the issuance of this Decision and Final Order. See 5 
U.S.C. 558(c). No evidence was put forward as to Trinity II's current 
licensure status with the Florida Department of Health.
---------------------------------------------------------------------------

    \9\ In accordance with the Administrative Procedure Act (APA), 
an agency ``may take official notice of facts at any stage in a 
proceeding--even in the final decision.'' U.S. Dept. of Justice, 
Attorney General's Manual on the Administrative Procedure Act 80 
(1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).
---------------------------------------------------------------------------

The Investigation of Trinity II

    On February 10, 2014, DEA Investigators (``DI'' or ``DIs'') 
conducted inspections of Trinity II. Tr. 119-20, 684-86, 709. The 
Government called three DIs as witnesses in its case-in-chief. See id. 
The lead investigator testified that when the DIs arrived at Trinity II 
for the inspection, they asked to speak to Trinity II's pharmacist-in-
charge (``PIC'') or owner and were greeted by Mr. Mark Abdelmaseeh, who 
identified himself as Trinity II's PIC. Id. at 124-26. The DIs 
presented Trinity II's PIC with a Notice of Inspection, and the PIC 
consented to the inspection after reviewing the Notice. Id. at 126. The 
lead investigator also testified that the DIs obtained, by consent from 
Trinity II, photocopies of the driver's licenses of the employees 
present when the investigators arrived and the original prescriptions 
for the two-year period of February 2012 to February 2014. Id. at 127-
32, 135-36.\10\ Another DI separately testified that his role during 
the inspection included identifying employees at the pharmacy and 
obtaining copies of their drivers' licenses. Id. at 686-88, 694. He 
also spoke with some of Trinity II's employees to obtain their job 
descriptions. Id. at 688-89.
---------------------------------------------------------------------------

    \10\ The lead investigator also testified that during the 
inspection of Trinity II, DIs reviewed DEA-222 order forms and the 
CSOS electronic ordering system. Tr. 134. He testified that CSOS, 
which stands for Controlled Substance Ordering System, provides an 
electronic version of the DEA-222 order form. Id. at 134-35.
---------------------------------------------------------------------------

    The lead investigator also testified that during the inspection at 
Trinity II, some employees represented to him that the pharmacy only 
dispensed controlled substances to patients with Florida addresses, 
that the pharmacist inspected each prescription for alteration or 
forgery, and that each physician's status was confirmed through the 
Florida Department of Health website. Id. at 577-78, 595-97. He also 
testified that someone at Trinity II claimed that its computer software 
``automatically confirmed the prescriber's DEA registration.'' Id. at 
578, 595-97. He further testified that the owners of the pharmacy, Mina 
and Emad Yousef, told him that they would call the doctor's office--a 
practice followed at Trinity I and Trinity II; however, the DI also 
testified that he did not recall either of them telling him that the 
owners called a doctor's office for every controlled substance 
prescription and exactly what they would discuss with the doctor. Id. 
at 126, 133, 579, 595-97, 666-67. He testified that the majority of 
prescriptions contained no evidence that anyone at Trinity II had 
called a doctor's office, and that neither the patient profiles nor the 
dispensing reports that he reviewed reflected such contacts. Id. at 
666-68. He also testified that Yousef told him during the inspection 
that the pharmacist would check the patient profile for medication 
history. Id. at 597.
    The lead investigator testified that he reviewed the original 
prescriptions and ``looked for the red flags of diversion that we had 
been trained on,'' such as distances, drug cocktails, drug 
interactions, and short fills. Id. at 147. He also reviewed them to 
make sure that the prescriptions included all of the required 
information such as the doctor's signature, patient name, patient 
address, and drug strength. Id. He then identified any prescriptions 
that were of interest and copied such prescriptions for review by the 
expert. Id. at 147-48, 538. He testified that the investigators did not 
make a forensic image of Trinity II's computer system. Id at 137.
    In addition to the prescriptions obtained by DEA during the 
inspection of Trinity II, the DIs obtained dispensing reports \11\ in 
May 2014 pursuant to a DEA administrative subpoena issued to Trinity II 
by facsimile. Id. at 156-57, 543 (``global dispensing report''), 544-
45. The May 9, 2014 subpoena specifically asked for Trinity II to 
provide, for the time period of February 10, 2012 through February 10, 
2014, ``[d]ispensing records of controlled substances in schedules II-V 
to include: Prescription number; patient's full name, date of birth, 
and address; drug name, strength, dosage form, quantity prescribed, and 
directions for use; prescriber's full name, address, and DEA number; 
method of payment; whether it is a new prescription or refill; and the 
pharmacist who filled [the] prescription.'' GX 95, at 4; Tr. 157-58, 
201-02, 608. On May 21, 2014, counsel for Respondents Trinity I and 
Trinity II, Mr. Dale Sisco, emailed to the lead investigator Trinity 
II's response to the administrative subpoena, which included a 
Microsoft Excel spreadsheet of Trinity II's dispensing report 
(hereinafter, ``global dispensing report'') as an attachment to that 
email. GX 96; Tr. 158, 172-73, 175, 627, 643.\12\ The DI testified that 
after receiving this global dispensing report, he created individual 
dispensing reports for individual patients to see the dispensing 
history for certain patients, and then he matched the original 
prescriptions with the dispensing report. Tr. 180-81, 219, 227.\13\ He 
also noted that the global dispensing report included a ``Filled By'' 
column which either contained the initials ``EFY,'' ``MAG,'' or 
``MIA.'' Id. at 271-72, 338, 344, 345.
---------------------------------------------------------------------------

    \11\ Because witnesses and counsel used the phrases ``dispensing 
report'' and ``dispensing log'' interchangeably throughout the 
hearing, I also use those phrases interchangeably in this decision.
    \12\ Government Exhibit 84 is a printed copy of the global 
dispensing report entered into evidence. Tr. 177-79.
    \13\ The lead investigator also testified that when he created 
the individual dispensing reports, using the global dispensing 
report, he did not alter any of the information in the global 
dispensing report, and that the individual dispensing reports are 
true and accurate representations of the information contained in 
the global dispensing report. Id. at 241, 247-48, 253, 256, 259, 
264, 268, 278, 285, 291-92, 297, 303-04, 348-49.
---------------------------------------------------------------------------

    On October 16, 2014, two DIs and Government counsel met with 
Trinity II's counsel, Mr. Sisco, and the co-owners of Trinity II--Emad 
Yousef and

[[Page 7310]]

Mina Yousef \14\--at Mr. Sisco's office. Id. at 186-88. The purpose of 
the meeting was to ask the Yousefs about information contained on the 
fill stickers of the prescriptions. Id. at 188-89. Emad Yousef was 
asked what ``MAG'' stood for, and the lead investigator testified that 
Yousef responded that it stood for Mina Ghobrial, a pharmacist intern 
at Trinity II. Id. at 339, 446-47. The DI testified that he conducted a 
license verification on Florida's Department of Health license 
verification website and learned that Mina Ghobrial is a pharmacist 
intern in Florida. Id. at 339, 444. Another DI testified that he also 
conducted the same license verification search on August 20, 2015 that 
confirmed Mr. Ghobrial's status as a licensed pharmacy intern. Id. at 
711; GX 78. The lead investigator also testified that ``EFY'' are the 
initials for Emad Yousef, and ``MIA'' are the initials for pharmacist 
Mark Abdelmaseeh. Tr. 271-72, 338, 345.
---------------------------------------------------------------------------

    \14\ The lead investigator testified that, during the inspection 
of Trinity II, he spoke with Emad Yousef, and that Yousef had stated 
that he and his brother, Mina Yousef, were co-owners of Trinity I 
and Trinity II. Tr. 128, 133.
---------------------------------------------------------------------------

    On December 4, 2014, the lead investigator issued an administrative 
subpoena to Trinity II asking that the pharmacy ``provide a copy of the 
complete patient profile your pharmacy maintained pursuant to Florida 
Administrative Rule 64B16-27.800 (`Requirement for Patient Records')'' 
for 23 specific patients. GX 98, at 2; Tr. 159, 548-49. The CALJ took 
official notice of the version of this Rule applicable between February 
2012 and February 2014. ALJ Ex. 38. The Florida Board of Pharmacy 
adopted the Florida Administrative Rules pursuant to its authority 
under Chapters 465.022 and 465.0155 of the Florida Statutes. This Rule 
requires ``all pharmacies'' to ``maintain[ ]'' ``[a] patient record 
system . . . for patients to whom new or refill prescriptions are 
dispensed'' that ``shall provide for the immediate retrieval of 
information necessary for the dispensing pharmacist to identify 
previously dispensed drugs at the time a new or refill prescription is 
presented for dispensing.'' ALJ Ex. 38, at 1 (Rule 64B16-27.800(1)). 
The Rule also states that the ``pharmacist shall ensure that a 
reasonable effort is made to obtain, record and maintain'' certain 
patient-related information, including ``[p]harmacist comments relevant 
to the individual's drug therapy, including any other information 
peculiar to the specific patient or drug.'' Id. (Rule 64B16-
27.800(1)(f)). This Rule further requires the pharmacist to ``record 
any related information indicated by a licensed health care 
practitioner.'' Id. (Rule 64B16-27.800(2)). Finally, this Rule requires 
pharmacists to maintain ``[a] patient record for a period of not less 
than two years from the date of the last entry in the profile record'' 
in ``hard copy or a computerized form.'' Id. (Rule 64B16-27.800(3)).
    The lead investigator testified that he requested the patient 
profiles because ``another place to resolve red flags, from my training 
and experience, was in the patient profiles,'' and ``a lot of 
pharmacists, instead of writing it on the prescription, they will 
actually type it into a note section in the patient profile in the 
computer.'' Tr. 182, 572-73. He further testified that the patient 
profile is generally ``part of the pharmacy's electronic system, where 
it will list out the prescriptions that the individual patient has 
received. It also contains note sections and other information 
regarding the patient.'' Id. at 159. On December 22, 2014, Mr. Sisco 
sent an email to the lead investigator stating that ``[e]nclosed please 
find documents responsive to the referenced subpoena.'' GX 98, at 1. 
Attached to this email were patient profiles stored in portable 
document format (``PDF''). Id.; Tr. 159-60, 175, 182-83.
    The lead investigator testified that he reviewed all the 
prescriptions, dispensing reports, and patient records obtained from 
Trinity II and received from its counsel. Tr. 183-84, 241, 247-48, 253-
54, 256, 259, 264, 268, 278, 285, 291, 297, 303, 572-73, 666-67. He 
testified that none of the patient records received in response to the 
December 4, 2014 administrative subpoena contained a ``notes and 
comment section'' or documentation of contact with a doctor's office. 
Id. at 183-84, 667-68. He also testified that the majority of the 
prescriptions did not contain evidence that a doctor's office had been 
called. Id. at 666-67.
    Finally, he testified that he created Google Maps printouts to show 
certain patient's travel. Id. at 238. Specifically, he testified that 
when he created these maps, he would use the patient's home address as 
the starting point, the physician's address as the next stop, the 
pharmacy as the stop after that, and sometimes the patient's home 
address as the final stop. Id. at 237. The CALJ found that the 
testimony of each of the DIs called by the Government ``was 
sufficiently detailed, plausible, consistent and cogent to be fully 
credited in this recommended decision.'' R.D. at 14.

The Allegations of Dispensing Violations

    The lead investigator testified that DEA investigators provided the 
following information to Professor Paul Doering, M.S., the Expert for 
the Government: (1) Copies of the original prescriptions for certain 
patients flagged by the lead investigator, (2) a copy of all of the E-
FORCSE \15\ data for the Respondent from February 2012 to February 
2014, (3) the aforementioned individualized dispensing reports prepared 
by the lead investigator, (4) a copy of one of his DEA-6 \16\ forms, 
(5) the subpoenaed patients' profiles, and (6) maps for certain 
patients. Tr. 581, 589-90, 597-98, 601-02. Professor Doering testified 
that he also received an electronic copy of the ``master dispensing 
report'' for Trinity II. Id. at 861. He further testified that he 
relied on the following materials in forming his opinion in this case: 
``the dispensing logs, the copies of the individual prescriptions, the 
patient profiles, and what could best be called as Google Maps and/or 
MapQuest indicators of distances between two spots.'' Id. at 863.
---------------------------------------------------------------------------

    \15\ E-FORCSE stands for ``Electronic-Florida Online Reporting 
of Controlled Substances Evaluation'' and is the prescription drug 
monitoring program in Florida. Tr. 553, 857.
    \16\ A DEA-6 is the form where DIs write their report of an 
investigation. Tr. 582. Pursuant to 21 CFR 1316.46(b)(4), the 
information contained in investigatory reports are not available for 
inspection as part of the administrative record. Thus, the CALJ 
properly precluded Respondents' counsel from asking the agent on 
cross-examination to reveal the contents of his DEA-6. Tr. 583 (``He 
can't be compelled to answer or reveal anything that's in his DEA-
6.''), 584 (``he can't be compelled to discuss the investigative 
contents of the DEA-6'').
---------------------------------------------------------------------------

    Professor Doering was retained by the Government to be its Expert 
and was tendered as such at the hearing. Tr. 147, 834. Professor 
Doering has taught the practice of pharmacy in Florida for 40 years and 
at one time also worked in a retail pharmacy. Id. at 812-13, 824, 830-
31; GX 32. His teaching has included courses related to the standards 
of pharmacy practice in the State of Florida. Tr. 814-15. He has also 
conducted research and published extensively regarding the standards of 
pharmacy practice in Florida. Id. at 816-17; GX 32. Professor Doering 
was also the one professor to have ever been given the honorary title 
of Distinguished Service Professor Emeritus in the 95-year history of 
the University of Florida's School of Pharmacy, a status he received in 
2011.\17\ Tr. 811-12.

[[Page 7311]]

Professor Doering testified that he keeps current on the latest 
developments in pharmacy practice. Id. at 817.
---------------------------------------------------------------------------

    \17\ According to his CV, he was ``[a]warded `Emeritus' status 
upon official retirement on January 31, 2011. Despite retirement, 
[he] continues to teach the same course as before retirement, except 
on a volunteer basis. [He e]ngages in special projects for the 
College of Pharmacy, Shands Hospital, and other agencies and 
organizations.'' GX 32, at 1.
---------------------------------------------------------------------------

    At the hearing, the CALJ accepted Professor Doering as an expert in 
the practice of pharmacy in the State of Florida and in the standard of 
care for pharmacists in the dispensing of controlled substances in 
Florida. Id. at 843-844. In his Recommended Decision, the CALJ also 
stated that Professor Doering ``has decades of experience in academia 
with honors and numerous publications'' and that ``[h]is credentials 
are extremely impressive, and the pride and commitment he displayed 
toward the field of pharmacy were undeniable and palpable in his 
testimony.'' R.D. at 14.
    In that capacity, Professor Doering testified that he sought to 
``identify[ ] individual patients that might demonstrate some of the 
activities and issues that have come to be called red flags'' or 
``indicators.'' Id. at 864. In his opinion, a red flag is ``anything 
that raises concern.'' Id. ``In the area of pharmacy it's a term that's 
come to be used to give examples to pharmacies of things that might 
indicate or suggest that prescriptions were filled outside the usual 
course of pharmacy practice.'' Id. He also testified that a red flag 
``could be indicative of abuse or misuse,'' ``over or under 
compliance,'' ``drug-drug interactions,'' or a ``forged'' or 
``altered'' prescription. Id. at 869. He further testified that these 
issues would be reviewed and resolved by a pharmacist ``before filling 
any prescription'' as part of the ``prospective drug utilization 
review, or prospective drug use review.'' See id. Resolution of red 
flags, he continued, ``would be documented on the face of the 
prescription, on the rear of the prescription, or in the patient 
profile.'' Id. at 882. Professor Doering testified that the standard of 
practice in Florida regarding the contents of such documentation is 
that it has to include ``a reason that makes sense that, to the average 
pharmacist, is understandable how a person could find themselves in 
that predicament,'' and the standard of practice also requires 
documentation of ``potentially reasonable removals of red flags'' and 
some link back to the prescribing physician. Id. at 1169-70. He further 
testified that ``if it's not written down[,] you didn't do it.'' Id. at 
1353.
    Professor Doering testified that the standard of care for a 
prospective drug utilization review (also referred to as a prospective 
drug use review) is already ``specified in the Florida Administrative 
Code,'' which requires pharmacists to perform a prospective drug 
utilization review before dispensing a medication. Id. at 869-70 (``It 
says, pharmacists shall, before dispensing a medication, perform what 
[is] called . . . prospective drug utilization review.''), 958-59 
(``it's crystal clear what it says, the pharmacist shall before 
dispensing any prescription do a drug utilization review''). The CALJ 
took official notice of (and entered into evidence) the applicable 
version of Florida Administrative Code Rule 64B16-27.810, entitled 
``Prospective Drug Use Review,'' which states that ``[a] pharmacist 
shall review the patient record and each new and refill prescription 
presented for dispensing in order to promote therapeutic 
appropriateness by identifying: (a) Over-utilization [ ]; (b) 
Therapeutic duplication; . . . (d) Drug-drug interactions; (e) 
Incorrect drug dosage or duration of drug treatment; . . . (g) Clinical 
abuse/misuse.'' ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)); Tr. 
946, 1852. This Rule also states that, ``[u]pon recognizing any of the 
above, the pharmacist shall take appropriate steps to avoid or resolve 
the potential problems which shall, if necessary, include consultation 
with the prescriber.'' Id. (Fla. Admin. Code Rule 64B16-27.810(2)). 
This prospective drug use review, according to Professor Doering, 
applies to all prescription drugs, including prescriptions for 
controlled substances and narcotics.\18\ See Tr. 870.
---------------------------------------------------------------------------

    \18\ Professor Doering testified that ``[n]arcotics 
prescriptions . . . are referred to as high alert medications'' that 
``have a higher than ordinary potential to cause harm if used 
inappropriately.'' Tr. 865, 867-68.
---------------------------------------------------------------------------

    Professor Doering testified that the drug utilization review 
process ``begins when the prescription is presented'' and should be 
``performed at the time the information is given to the pharmacist.'' 
Id. at 873. He also stated that the standard of care in Florida 
requires pharmacists to use the notes and comments fields in a patient 
profile to document the resolution of issues identified during the drug 
utilization review process. Id. at 1015-16. In the absence of notes 
resolving such issues in the patient profile, Professor Doering 
testified that he would also look to the front and back of the 
prescription to determine whether a pharmacist had resolved a red flag. 
Id. at 1055, 1101. He further testified that he did not find any notes 
and comments section in any of the patient profiles he reviewed.\19\ 
Id. at 1054, 2087.
---------------------------------------------------------------------------

    \19\ Professor Doering testified that he also reviewed 
dispensing logs, which are typically ``spreadsheet[s] that contain[ 
] information regarding drugs that were dispensed by the pharmacy,'' 
and that the data in the dispensing log should ``correspond'' to the 
patient profile's data. Tr. 1018-19.
---------------------------------------------------------------------------

    Professor Doering testified that only after the pharmacist has 
identified, resolved, and documented his/her resolution of red flags of 
diversion and other issues identified during the drug utilization 
review process can the pharmacist fill the prescription. Id. at 873-74, 
1093-94, 1099-1100. If the pharmacist cannot resolve the issue, then 
the standard of care calls for pharmacists not to fill the 
prescription. E.g., id. at 879.
    Professor Doering also explained some specific issues, or red 
flags, that pharmacists must look for as part of the prospective drug 
review process pursuant to Rule 64B16-27.810. For instance, he 
testified that the term ``over-utilization'' in this Rule is a red 
flag, and he explained that it ``can be two things. So it can be taking 
more of the medication at a single administration. Or it could be 
obtaining more medication than the physician had desired, and using it 
in a time span that is less than the medication was supposed to last.'' 
ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(a)); Tr. 872, 876. He 
offered the following example: ``So if it's a 30-day supply of 
medicine, having lasted only 15 days is suggestive of one of two 
things. One, is taking too much of it. Or two, might be distributing it 
to other persons. That would be over[-] utilization.'' Id. at 872. He 
testified that when a pharmacist identifies an over-utilization issue 
when a patient presents a prescription, the pharmacist must resolve 
that issue (and document that resolution) before filling the 
prescription. Id. at 873-74, 879.
    Professor Doering also explained that the term ``therapeutic 
duplication,'' as set forth in Rule 64B16-27.810(1)(b), ``is the 
presenting of two prescriptions, either for the identical drug, or 
drugs that are so closely allied that they would be overlapping in 
their actions in the body.'' Id. at 884-85, 1520 (therapeutic 
duplication'' occurs when ``two drugs with the same action [are] being 
prescribed under the same circumstances''), 1541 (``Essentially two 
drugs with the same net effect.''). ``[F]rom a pharmacist's standpoint, 
[that] is duplication of therapy.'' Id. at 885. Professor Doering 
testified that therapeutic duplication is a red flag. Id. at 886. 
``Therapeutic duplication signifies that there are two or more

[[Page 7312]]

drugs that appear to be essentially doing the same thing, that together 
might pose the issue of adverse drug-drug interactions.'' Id. at 883; 
see ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(b), (d)). ``[I]t 
also may involve intentional duplication of drugs.'' Tr. 883. In this 
way, he added that a prescription raising a ``therapeutic duplication'' 
concern might lead to another issue for the pharmacist to resolve 
regarding drug-drug interactions. Id. at 883-84. As a result, Professor 
Doering stated that therapeutic duplication raises many concerns, 
including the ``safety of the patient. But it could also indicate an 
attempt to obtain more medication for over[-]utilization, which touches 
upon some of the other issues, which means clinical use or abuse, or 
diversion to some other use.'' Id. at 885-86. As with other red flags, 
he reiterated that the standard of care requires pharmacists receiving 
a prescription raising the red flag of therapeutic duplication to 
resolve that issue (and document such resolution) before filling the 
prescription. Id. at 886-91.
    Professor Doering next explained the term ``[d]rug-drug 
interactions.'' ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(d)). 
He testified that this ``refers to the fact that two drugs, when given 
together, can have outcomes that are not what was intended initially by 
either one or the other drug together.'' Tr. 893. He testified that 
when presented with prescriptions presenting potentially harmful drug-
drug interactions, the standard of care requires the pharmacist to 
either (1) resolve this red flag and document the resolution once the 
pharmacist is satisfied that it is in the best interest of the patient, 
or (2) not fill the prescriptions. Id. at 1419-20.
    Professor Doering also testified, however, that drug cocktails that 
include an opioid, benzodiazepine, and a muscle relaxer present red 
flags that must be resolved. See, e.g., id. at 1413-16, 1427. ``[F]or 
example, oxycodone, or some other potent narcotic, along with a 
tranquilizer drug, such as alprazolam or Xanax, combined with a muscle 
relaxant, say for example, Soma,'' also known as carisoprodol. Id. at 
894. ``[T]hose three drugs, which have been come to be called the 
unholy trinity, or . . . cocktail prescriptions, whatever you want to 
call them, are symbolic of drug interactions that might cause harms to 
the patient.'' Id.; see also id. at 1416-17. According to Professor 
Doering's testimony, these drugs ``have added central nervous system 
depressant properties and can present a real and present danger to the 
patient.'' Id. at 1417. Moreover, he testified that this combination of 
drugs ``constitute what I would call drugs with abuse potential, 
serious abuse potential'' and ``are often diverted to non-medical or 
recreational use.'' Id. at 1416.\20\ During the prospective drug 
utilization review process, pharmacists, ``check for drug/drug 
interactions. And this would be subject to, in my opinion, very severe 
drug/drug interactions.'' Id. at 1418.
---------------------------------------------------------------------------

    \20\ He also testified that ``[t]he nature of the drug 
combination, a potent narcotic analgesic, along with a potent 
anxiolytic medicine, along with a potent muscle relaxant . . . It's 
just come to be associated with a high potential for abuse.'' Tr. 
1417.
---------------------------------------------------------------------------

    Professor Doering testified to what a pharmacist would look for in 
identifying ``[c]linical abuse/misuse'' as part of the prospective drug 
use review. ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(g)). He 
defined clinical abuse or misuse as ``recreational use'' or ``drug 
abuse'' which ``typically involves taking more of the prescribed drug 
or focusing on certain drugs that have [ ] mood altering properties . . 
. that individuals . . . will use for other than medical purposes.'' 
Tr. 952, 953 (it is ``any time you use the drug outside the conditions 
for which it could be prescribed''). To identify such clinical abuse/
misuse as part of the drug utilization review process, Professor 
Doering testified that a pharmacist ``would look for quantities of 
drugs that are being sought beyond those which were authorized by the 
prescriber or they might look for certain combinations of drugs that 
are known to be used frequently for non-medical reasons.'' Id. at 953. 
Again, as with the other red flags that may arise during a prospective 
drug use review (i.e., the drug utilization review process), if the 
pharmacist cannot resolve the clinical abuse/misuse red flag, then he 
or she must not fill the prescription. Id.at 955.
    Professor Doering also offered testimony regarding patient address 
information that appears on a prescription and the distance a patient 
travels to a pharmacy to fill a prescription. He testified that both 
Florida and federal law require a patient's address to appear on 
prescriptions ``so that the pharmacist has some idea of where this 
patient resides and that can be useful for a couple of different 
reasons . . . it's also useful to know what geographic area this 
patient lives in because that may become important information as the 
prospective drug use review takes place.'' Id. at 973. In the same 
vein, he testified that a physician's address must also appear on the 
prescription to indicate where the patient met with the practitioner. 
Id. at 970. ``Typically you would look to patients that are in the same 
geographic area [as the pharmacy]. I would say within the same county 
or geographic area.'' Id. at 1692. ``[W]hen the distances are very 
great, it raises . . . a question of why is somebody needing to travel 
this far to get this prescription filled.'' Id.
    Professor Doering also explained what type of information is 
generated after a pharmacist has decided to fill a prescription. ``When 
the computer prints out the information there are different versions of 
the [fill sticker]. One version of it doesn't contain necessarily all 
this information, but that's the one that gets applied to the 
prescription vial. Th[e other version] is the one for pharmacists' 
record keeping purposes. It has additional info that the one on the 
vial does not.'' Id. at 978.
    Significantly, he testified that the fill sticker is generated 
after the drug utilization review process has been completed, and that 
the date appearing on the fill sticker represents the date when the 
pharmacy filled the prescription. Id. at 979-80. He explained that the 
fill sticker is ``generated one step before the prescription label is 
actually applied to the vial . . . by the pharmacist. The significance 
of that is that the prescription has gone through all the proper steps 
and its certified ready for dispensing to the patient.'' Id. at 979. 
Professor Doering further testified that, in his opinion, the date on 
the fill sticker also represents when the prescription is dispensed. 
Id. at 1186.
    Respondents did not proffer an expert witness at the hearing, and I 
find that Professor Doering's testimony was credible.\21\
---------------------------------------------------------------------------

    \21\ Although the CALJ expressly declined to offer a view of 
Professor Doering's credibility, he nonetheless disregarded his 
opinions as ``insufficiently reliable to form the basis of a 
sanction under the APA.'' R.D., at 33 (``To be clear, however, this 
is not an issue of credibility, and no credibility determination is 
entered here.''). As I discuss infra, I disagree with the CALJ's 
assessment of the expert's reliability.
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The Prescription Evidence

    At the hearing, the Government introduced into evidence copies of 
dispensing logs, patient profiles, and the front and back of 
prescriptions for controlled substances which it alleged Trinity II 
filled in violation of 21 CFR 1306.04(a) and 1306.06 because they 
presented red flags of diversion that Trinity II failed to resolve as 
set forth in the first two charges of the Show Cause Order. As already 
noted, the first charge of the Show Cause Order outlined six different 
categories of red flags of diversion that the Government alleged

[[Page 7313]]

that Trinity II failed to resolve before filling the pertinent 
prescriptions. When taken together, the Government alleged that Trinity 
II's failure to resolve these red flags before filling these 
prescriptions demonstrated that Trinity II knowingly filled 
prescriptions for controlled substances in contravention of its 
corresponding responsibility and outside the usual course of pharmacy 
practice.
Early Fills
    The Government introduced prescription evidence to show that 
Trinity II failed to resolve the first alleged red flag of diversion, 
``early fills,'' with respect to at least four of its customers 
identified in the first charge of the Show Cause Order and whose 
patient records the Government had requested pursuant to its December 
4, 2014 subpoena.\22\ For one such customer, J.T., the Government 
introduced a dispensing log, patient profile, and the front and back of 
prescriptions to establish that Trinity II filled early at least nine 
prescriptions issued to J.T. for oxycodone 30 milligrams (hereinafter, 
``mg''), a schedule II controlled substance, under the brand name 
Roxicodone. GX 35; Tr. 1198-1234. Specifically, the Government 
introduced evidence that on February 23, 2012, Trinity II filled a 
prescription issued by physician W.F. to customer J.T. for 336 pills of 
``Roxicodone 30 mg,'' and with directions from the prescribing 
physician for J.T. to take up to eight pills per day. GX 35, at 1, 3, 
10, 11; Tr. 1199-1202. Although the fill sticker and patient profile 
both state that the prescription was for a 30-day supply, in fact, the 
336 pills prescribed to be taken at the rate of eight pills per day 
constitutes a 42-day supply that should have lasted J.T. until at least 
April 6, 2012. Id. Nevertheless, on March 22, 2012, Trinity II then 
filled another prescription (from the same prescriber) for another 336 
pills of Roxicodone 30 mg with instructions to take up to eight pills 
per day. GX 35, at 1, 3, 16, 17; Tr. 1202-05. Thus, I find that when 
Trinity II filled this second prescription on March 22, 2012, Trinity 
II filled it 15 days early. Accord Tr. 1205.\23\ I also find that the 
front of the prescription, the back of the prescription bearing the 
fill sticker, the patient profile, and the dispensing log do not 
reflect any notes or comments explaining why Trinity II filled the 
prescription early. GX 35, at 1, 3, 15, 16; Tr. 1198, 1199, 1205-06.
---------------------------------------------------------------------------

    \22\ For reasons I discuss infra, and as it relates to the first 
and second charges of the Show Cause Order only, I limit my fact 
findings to evidence related to those patients discussed at the 
hearing who were also identified in the December 4, 2014 subpoena.
    \23\ Notably, the CALJ failed to make recommended fact findings 
related to the alleged early fills, or most of the other allegations 
set forth in paragraphs 7-8 of the Show Cause Order (i.e., the first 
two charges of the Order) because of his concerns related to 
Professor Doering's reliability as an expert. R.D., at 43. However, 
as discussed further infra, this concern, even if well-founded, does 
not categorically relieve the Agency from making fact findings on 
allegations about Trinity II's filling conduct that can be decided 
without expert opinion. Accordingly, I will make such ultimate fact 
findings, even where the CALJ chose not to recommend any.
---------------------------------------------------------------------------

    Professor Doering testified that, in Florida, whereas a fill (or 
refill) that is 2-3 days early may not signify a problem, a fill that 
is more than two-to-three days early is a red flag that a pharmacist is 
expected to resolve during the drug utilization review process ``to 
avoid overuse or misuse.'' See Tr. 989-91, 1009. ``If someone is coming 
back fifteen days early, then that signifies a problem.'' Id. at 990. 
In the case of J.T.'s presentation of the aforementioned March 22, 2012 
Roxicodone 30 mg prescription 15 days early, the evidence established 
that there are no notes or comments--much less any evidence that 
Trinity II resolved this red flag--reflected in J.T.'s patient profile, 
dispensing log, or the front-and-back of this prescription. GX 35, at 
1, 3, 15, 16; Tr. 1198-99, 1205-06. As a result, Professor Doering 
testified that this prescription was inconsistent with Florida's 
standard of care, not filled in the usual course of professional 
practice, nor filled in the proper exercise of the pharmacist's 
corresponding responsibility. Id. at 1206.
    In each of the next eight months, J.T. presented prescriptions to 
Trinity II for Roxicodone 30 mg in the same quantities and with the 
same dosing instructions; and in each instance, I find that Trinity II 
filled those prescriptions 14, 15, or 16 days early. GX 35, at 1, 3, 
16, 17, 20, 21; Tr. 1208-09 (prescription for 42-day supply that 
Trinity II filled 15 days early on April 19, 2012); GX 35, at 1, 3, 20, 
21, 30, 31; Tr. 1209-12 (prescription for 42-day supply that Trinity II 
filled 15 days early on May 17, 2012); GX 35, at 1, 3, 30, 31, 36, 37; 
Tr. 1213-17 (prescription for 42-day supply that Trinity II filled 15 
days early on June 14, 2012); GX 35, at 1, 3, 36, 37, 44, 45; Tr. 1220-
23 (prescription for 42-day supply that Trinity II filled 15 days early 
on July 12, 2012); GX 35, at 1, 3, 44, 45, 50, 51; Tr. 1223-25 
(prescription for 42-day supply that Trinity II filled 16 days early on 
August 8, 2012); GX 35, at 1, 3, 50, 51, 54, 55; Tr. 1225-28 
(prescription for 42-day supply that Trinity II filled 14 days early on 
September 6, 2012); GX 35, at 1, 3, 54, 55, 62, 63; Tr. 1228-31 
(prescription for 42-day supply that Trinity II filled 16 days early on 
October 3, 2012); GX 35, at 1, 3, 62, 63, 70, 71; Tr. 1231-34 
(prescription for 42-day supply that Trinity II filled 14 days early on 
November 1, 2012). When considering the cumulative effect of these 
consecutive monthly early fills from March-November 2012, I find that 
Trinity II filled prescriptions for J.T. that resulted in the filling 
of 135 days of extra oxycodone 30 mg.
    And as with the earlier prescription that Trinity II filled for 
J.T. on March 22, 2012, I find that the prescriptions (front or back), 
patient profile, and dispensing log do not reflect any notes or 
comments, much less documentation, explaining how Trinity II resolved 
the early refill red flag presented by these prescriptions over the 
eight subsequent months. See GX 35, at 1, 3, 16, 17, 20, 21, 30, 31, 
36, 37, 44, 45, 50, 51, 54, 55, 62, 63, 70, 71; Tr. 1198-99, 1205-06, 
1212, 1216, 1218, 1222, 1225, 1228, 1230, 1234. And in each instance, 
Professor Doering testified that, because all of these early fills were 
well beyond 3 days early, Trinity II should have identified these early 
fills as red flags during the drug utilization review process to avoid 
drug abuse, overuse or misuse. Tr. 1208-09, 1211-12, 1215-17, 1222-25, 
1227-28, 1230-31, 1234. He further testified that Trinity II's decision 
to fill these prescriptions without resolving these red flags was 
inconsistent with Florida's standard of care, not in the usual course 
of professional practice, and did not reflect the proper exercise of 
the pharmacist's corresponding responsibility. Id.
    For a second customer, M.A., the Government introduced a dispensing 
log, patient profile, and the front and back of prescriptions to 
establish that Trinity II filled early at least 8 prescriptions issued 
to M.A. for hydromorphone 8 mg, a schedule II controlled substance, 
under the brand name Dilaudid. GX 36; Tr. 1237-68. The Government 
introduced evidence that on May 2, 2013, Trinity II filled a 
prescription issued by physician R.A. at the Genesis Medical Clinic to 
customer M.A. for 165 pills of ``Dilaudid Oral Tablet 8 MG,'' with 
directions from the prescribing physician for M.A. to ``[t]ake one 
tablet every 5 to 6 hours for 30 days.'' GX 36, at 1-2, 4-5; Tr. 1237-
42. Although the prescription and the fill sticker both stated that the 
prescription was for a 30-day supply, in fact, the 165 pills prescribed 
to be taken at the rate

[[Page 7314]]

of five pills \24\ per day constitutes a 33-day supply that should have 
lasted M.A. until at least June 4, 2013. Id. Nevertheless, on May 28, 
2013, Trinity II then filled another prescription (from another 
prescriber, J.S., at the same practice group--Genesis Medical Clinic) 
for another 165 pills of Dilaudid 8 mg with instructions to take one 
tablet every five to six hours for 30 days. GX 36, at 1-2, 4-7; Tr. 
1242-45. Thus, I find that when Trinity II filled this second 
prescription on May 28, 2013, Trinity II filled it seven days early. I 
also find that the front of the prescription, the back of the 
prescription bearing the fill sticker, the patient profile, and the 
dispensing log do not reflect any notes or comments explaining why 
Trinity II filled the prescription early. GX 36, at 1-2, 6-7; Tr. 1236, 
1237, 1245.
---------------------------------------------------------------------------

    \24\ If M.A. took the tablets every six hours as instructed, 
then the daily tablet dosage would be four tablets/day; if M.A. took 
the tablets every five hours as alternatively instructed, then the 
daily dosage would be 4.8 tablets per day. Accord Tr. 1239-40. For 
purposes of this early fill fact-finding, I will round up to and use 
the rate of five tablets/day--a calculation that offers Trinity II 
the greatest lenity for purposes of calculating an early fill.
---------------------------------------------------------------------------

    In each of the next seven months, M.A. presented to Trinity II 
prescriptions from the same Genesis Medical Clinic for Dilaudid 8 mg in 
the same quantities and with the same dosing instructions; and in each 
instance, I find that Trinity II filled those prescriptions six days 
early. GX 36, at 1-2, 6-9; Tr. 1245-49 (prescription for 33-day supply 
that Trinity II filled six days early on June 25, 2013); GX 36, at 1-2, 
8-10; Tr. 1249-51 (prescription for 33-day supply that Trinity II 
filled six days early on July 23, 2013); GX 36, at 1-2, 10-11; Tr. 
1251-54 (prescription for 33-day supply that Trinity II filled six days 
early on August 20, 2013); GX 36, at 1-2, 11, 13-14; Tr. 1254-55 
(prescription for 33-day supply that Trinity II filled six days early 
on September 17, 2013); GX 36, at 1-3, 13-16; Tr. 1256-58 (prescription 
for 33-day supply that Trinity II filled six days early on October 15, 
2013); GX 36, at 1, 3, 15-18; Tr. 1259-61 (prescription for 33-day 
supply that Trinity II filled six days early on November 12, 2013); GX 
36, at 1, 3, 17-20; Tr. 1262-64 (prescription for 33-day supply that 
Trinity II filled six days early on December 10, 2013). When 
considering the cumulative effect of these consecutive monthly early 
fills from May 2013 to December 2013, I find that Trinity II filled 
prescriptions for M.A. that resulted in the filling of 50 days of extra 
hydromorphone 8 mg.
    As with the earlier prescription that Trinity II filled for M.A. on 
May 28, 2013, I find that the prescriptions (front or back), patient 
profile, and dispensing log do not reflect any notes or comments, much 
less documentation, explaining how Trinity II resolved these early 
refill red flags over the seven subsequent months. See GX 36, at 1-3, 
4-11, 13-20; Tr. 1236-37, 1245, 1248, 1251, 1253, 1255, 1258, 1261, 
1263. Professor Doering testified that, because all of these early 
fills were well beyond three days early, Trinity II should have 
identified these early fills as red flags during the drug utilization 
review process to avoid drug abuse, overuse or misuse. Tr. 1240-41, 
1245, 1248-49, 1251, 1253-54, 1255, 1256, 1258, 1261, 1263-64. He 
further testified that Trinity II's decision to fill these 
prescriptions without resolving these red flags was inconsistent with 
Florida's standard of care, not in the usual course of professional 
practice, and did not reflect the proper exercise of the pharmacist's 
corresponding responsibility. Id.
    For a third customer, J.G., the Government introduced a dispensing 
log, patient profile, and the front and back of prescriptions to 
establish that Trinity II filled early or refilled early prescriptions 
issued to J.G. at least seven times--one time for a prescription of 
lorazepam 2 mg, and six times for prescriptions of alprazolam 2 mg, 
both of which are schedule IV controlled substances. GX 39; Tr. 1364-
84. Regarding the lorazepam prescription, the Government introduced 
evidence that on May 29, 2012, Trinity II filled a prescription issued 
by physician G.C. to customer J.G. for 30 pills of lorazepam 2 mg, and 
with directions from the prescribing physician for J.G. to ``[t]ake \1/
2\ [one-half of one] tablet(s) . . ., 2 times per day, for 30 days.'' 
GX 39, at 1-2, 4; Tr. 1365-66. Hence, the 30 pills prescribed to be 
taken at the rate of one pill per day constitute a 30-day supply that 
should have lasted J.G. until at least June 28, 2012. Id. Nevertheless, 
on June 19, 2012, Trinity II then filled another prescription from the 
same prescribing physician for another 30 pills of lorazepam 2 mg with 
the same instructions--one pill per day. GX 39, at 1-2, 4-5; Tr. 1366-
70. Thus, I find that when Trinity II filled this second prescription 
on June 19, 2012, Trinity II filled it nine days early. Accord Tr. 
1367. I also find that the front of the prescription, the back of the 
prescription bearing the fill sticker, the patient profile, and the 
dispensing log do not reflect any notes or comments explaining why 
Trinity II filled the prescription early. GX 39, at 1-2, 5; Tr. 1364-
65, 1369.
    With respect to the alprazolam prescriptions for J.G., the 
Government introduced evidence that on September 18, 2012, Trinity II 
filled a prescription issued by physician G.C. to customer J.G. for 30 
pills of Xanax 2 mg, which is the brand name for alprazolam 2 mg, that 
could be refilled twice and with directions from the prescribing 
physician for J.G. to ``[t]ake \1/2\ [one-half of one] tablet(s) . . ., 
2 times per day, for 30 days, as needed for anxiety.'' GX 39, at 1-2, 
6; Tr. 1370-71. Hence, the 30 pills prescribed to be taken at the rate 
of one pill per day constitute a 30-day supply that should have lasted 
J.G. until at least October 18, 2012 (assuming J.G. needed to take it 
every day for 30 days). Id. Nevertheless, the dispensing log and 
patient profile show that on October 10, 2012, Trinity II then refilled 
the prescription for another 30 pills of alprazolam 2 mg. GX 39, at 1-
2, 6; Tr. 1371-73. Thus, I find that when Trinity II refilled this 
prescription on October 10, 2012, Trinity II refilled it eight days 
early. Accord Tr. 1372. The dispensing log and patient profile also 
establish that on October 29, 2012, Trinity II refilled the 
prescription again for another 30 pills of alprazolam 2 mg. GX 39, at 
1-2, 6; Tr. 1373. Thus, I find that when Trinity II refilled this 
prescription on October 29, 2012, Trinity II refilled it 10 days early 
because the earlier refill should have lasted until November 8, 2012. 
Accord Tr. 1374. I also find that the front of the original 
prescription, the back of the original prescription bearing the fill 
sticker, the patient profile, and the dispensing log do not reflect any 
notes or comments explaining why Trinity II refilled the prescription 
early on October 10 and October 29, 2012. GX 39, at 1-2, 6; Tr. 1373.
    On February 26, 2013, Trinity II filled another prescription issued 
by physician G.C. to customer J.G. for 30 pills of alprazolam 2 mg (a 
30-day supply), even though the dispensing log and J.G.'s patient 
profile show that Trinity II had already filled a 30-day supply of 
alprazolam 2 mg for J.G. on February 14, 2013.\25\ GX 39, at 1-2, 8-9; 
Tr. 1375-77. I find that when Trinity II filled the February 26, 2013 
prescription, Trinity II filled it at least 17 days early because the 
February 14, 2013 refill should have lasted J.G. until at least March 
15, 2013. Accord Tr. 1377. Over the next two months, Trinity II then 
refilled this prescription twice (on March 18, 2013 and on April 12,

[[Page 7315]]

2013), and in each instance I find that Trinity II refilled it 10 and 
five days early, respectively. GX 39, at 1-2, 9; Tr. 1377-79 
(prescription for 30-day supply that Trinity II filled 10 days early on 
March 18, 2013); GX 39, at 1-2; Tr. 1377-79 (prescription for 30-day 
supply that Trinity II filled five days early on April 12, 2013). I 
find that the front of the original prescription, the back of the 
original prescription bearing the fill sticker, the patient profile, 
and the dispensing log do not reflect any notes or comments explaining 
why Trinity II filled the February 26, 2013 prescription early, and 
twice refilled that prescription early on March 18 and April 12, 2013. 
GX 39, at 1-2, 8-9; Tr. 1373, 1379.
---------------------------------------------------------------------------

    \25\ The February 14, 2013 filling by Trinity II was the second 
refill of a December 18, 2012 prescription (also issued by physician 
G.C.) that J.G. had filled at Trinity II on December 18, 2012. See 
GX 39, at 1-2, 8.
---------------------------------------------------------------------------

    In addition, even though Trinity II filled a new prescription for a 
30-day supply of alprazolam 2 mg issued by physician G.C. to J.G. on 
May 14, 2013 that should have lasted J.G. until at least June 12, 2013, 
Trinity II refilled this prescription with another 30-day supply of 
alprazolam 2 mg on June 6, 2013. GX 39, at 1, 3, 10; Tr. 1380-83. Thus, 
I find that the June 6, 2013 refill by Trinity II was six days early. 
Accord Tr. 1383. As with the other prescriptions and early fills and 
refills related to J.G., I find that the front of the original 
prescription, the back of the original prescription bearing the fill 
sticker, the patient profile, and the dispensing log do not reflect any 
notes or comments explaining why Trinity II filled and refilled the 
prescription early. GX 39, at 1, 3, 10; Tr. 1383.
    With respect to all the early fills and refills by Trinity II with 
respect to lorazepam 2 mg and alprazolam 2 mg prescriptions issued by 
physician G.C. to J.G., Professor Doering testified that, because all 
of these early fills and early refills were well beyond three days 
early, Trinity II should have identified them as red flags during the 
drug utilization review process to avoid drug abuse, overuse or misuse. 
Tr. 1369, 1372, 1374, 1377, 1383. He further testified that Trinity 
II's decision to fill these prescriptions without resolving these red 
flags was inconsistent with Florida's standard of care, not in the 
usual course of professional practice, and did not reflect the proper 
exercise of the pharmacist's corresponding responsibility. Id. at 1370, 
1373-74, 1377, 1379, 1384.
    For a fourth customer, L.H., the Government introduced a dispensing 
log, patient profile, and the front and back of prescriptions to 
establish that Trinity II filled early at least 2 prescriptions issued 
to L.H. for hydromorphone 8 mg, a schedule II controlled substance, 
under the brand name Dilaudid. GX 40; Tr. 1384-94. The Government 
introduced evidence that on June 5, 2012, Trinity II filled a 
prescription issued by physician J.I. at the Creative Health Center to 
customer L.H. for 180 pills of ``Dilaudid Tablet 8 mg,'' and with 
directions from the prescribing physician for L.H. to take one tablet 
by mouth every four hours as needed. GX 40, at 1, 3, 12-13; Tr. 1387-
88. Hence, the 180 pills prescribed to be taken at the rate of six 
pills per day constitute a 30-day supply that should have lasted L.H. 
until at least July 5, 2012 (assuming L.H. needed to take every dose, 
every day). Accord Tr. 1392. Nevertheless, on June 28, 2012, Trinity II 
filled another prescription (dated June 18, 2012 from another 
prescriber, E.P. at Morton Plant Hospital) \26\ for another 84 pills of 
Dilaudid 8 mg with instructions to take one tablet every 4 hours for 14 
days. GX 40, at 1, 4, 14-15; Tr. 1388-89, 1392. Thus, I find that when 
Trinity II filled this second prescription on June 28, 2012, Trinity II 
filled it at least seven days early. Accord Tr. 1389. On July 3, 2012, 
Trinity II filled a third prescription, this time from physician J.I. 
(who issued the June 5, 2012 prescription) to L.H., for another 96 
pills of Dilaudid 8 mg with instructions to take one tablet every four 
hours for 16 days. GX 40, at 1, 4, 16-17; Tr. 1392-93. As a result, I 
find that when Trinity II filled this third prescription on July 3, 
2012, Trinity II filled it nine days early because the June 28, 2012 
fill should have lasted L.H. until July 12, 2012. Accord Tr. 1393. I 
also find that the front of these prescriptions, the back of the 
prescriptions bearing the fill stickers, the patient profile, and the 
dispensing log do not reflect any notes or comments explaining why 
Trinity II filled these prescriptions early. GX 40, at 1-4, 12-17; Tr. 
1391, 1393-94.
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    \26\ The fact that the same patient, L.H., went to two different 
prescribers in the same month for the same schedule II drug also 
demonstrates the appearance of doctor shopping--another red flag of 
overuse or misuse. Professor Doering testified that this too should 
have been identified during the drug utilization process as 
indicative of overuse, misuse, or abuse. Tr. 1390. There is no 
evidence in the record that Trinity II attempted to resolve this red 
flag before filling the second of these prescriptions on June 28, 
2012. Professor Doering also testified that Trinity II's decision to 
fill the June 18, 2012 prescription on June 28, 2012 without 
resolving these red flags was inconsistent with Florida's standard 
of care, not in the usual course of professional practice, and did 
not reflect the proper exercise of the pharmacist's corresponding 
responsibility. Id. at 1391.
---------------------------------------------------------------------------

Therapeutic Duplication
    The Government introduced prescription evidence at the hearing to 
show that Trinity II failed to resolve the red flag of ``therapeutic 
duplication'' with respect to one of its customers, R.H., identified in 
the first charge of the Show Cause Order and whose patient records the 
Government had requested pursuant to its December 4, 2014 subpoena. The 
Government introduced a dispensing log, patient profile, and the front 
and back of prescriptions to establish that Trinity II filled two 
therapeutically duplicative prescriptions issued by physician J.I. for 
R.H. on December 2, 2013. The first prescription was for 120 tablets of 
hydromorphone 8 mg, an immediate release opioid under the Dilaudid 
brand name, with directions to ``Take 1 Tablet by Mouth Every 6 Hours 
As Needed.'' GX 63, at 1, 4-6; Tr. 1560-61. The second prescription was 
for 120 tablets of oxycodone 30 mg, another immediate-release opiate, 
with the same directions to take one tablet every six hours as needed. 
GX 63, at 1, 4, 7-8; Tr. 1561-63. I find that the front of the 
prescriptions, the back of the prescriptions bearing the fill stickers, 
the patient profile, and the dispensing log do not reflect any notes or 
comments explaining why Trinity II filled these two schedule II opiate 
prescriptions on December 2, 2013. GX 63, at 1, 4-8; accord Tr. 1563-
64.
    According to Professor Doering, when a Florida pharmacist receives 
two prescriptions from the same individual for two different opioids, 
both with the same or similar directions for use, and those two are 
immediate release dosage forms, the standard of care requires the 
pharmacist to identify that as a red flag and to initiate steps to 
resolve that red flag. Tr. at 2111. However, Professor Doering also 
testified that, in his opinion, the therapeutic duplication of 
hydromorphone and oxycodone with respect to R.H., or any other pharmacy 
customer, is not a resolvable flag. Id. at 1520, 1563. ``[P]harmacists 
would fall below the standard of care to dispense these two [opioids] 
together because of the inherent dangers that go along with giving both 
of these very potent narcotic analgesics . . . [t]hat could in fact be 
used together, at the same time.'' Id. at 1520. He also testified that 
therapeutic duplication should be identified during the drug 
utilization review process. Id. at 1526, 1541-42. Professor Doering 
testified that Trinity II's filling of these prescriptions for R.H. 
were inconsistent with the standard of care, not filled in the usual 
course of professional practice, and inconsistent with the proper 
exercise of the pharmacist's corresponding responsibility. Id. at 1563-
64.

[[Page 7316]]

Two Prescriptions for the Same Drug on the Same Date
    The Government introduced prescription evidence at the hearing to 
show that Trinity II failed to resolve the red flag of receiving two 
prescriptions for the same drug on the same date from the same customer 
(J.K.)--another form of ``therapeutic duplication.'' The customer, 
J.K., was identified in the first charge of the Show Cause Order, and 
the Government had requested his patient records pursuant to its 
December 4, 2014 subpoena. The Government introduced a dispensing log, 
patient profile, and the front and back of prescriptions to establish 
that Trinity II filled two prescriptions issued by physician M.L. for 
J.K. on the same day--December 4, 2013. The first prescription was for 
100 tablets of hydromorphone 8 mg, under the Dilaudid brand name, with 
instructions that the patient take one tablet every four to six hours--
a 16-day supply. GX 69, at 1, 3-5; Tr. 1584-86. The second prescription 
was for 50 tablets of Dilaudid 8 mg with the same directions for use--
an eight-day supply. GX 69, at 1, 3, 6-7; Tr. 1584-86. The dispensing 
log also shows that J.K. paid ``cash'' for these two prescriptions, 
just as he had for every other prescription that Trinity II had filled 
for J.K. between March 5, 2012 and February 3, 2014. GX 69, at 1. 
According to Professor Doering, two prescriptions for the same 
medication filled on the same date for the same customer is an 
unresolvable red flag of diversion that should have been identified 
during the drug utilization process. Tr. 1568, 1586-87. Regardless of 
whether it is resolvable, I find that the front of the prescriptions, 
the back of the prescriptions bearing the fill stickers, the patient 
profile, and the dispensing log do not reflect any notes or comments 
explaining why Trinity II filled these two prescriptions for the same 
drug and for the same customer (J.K.) on December 4, 2013. GX 69, at 1, 
3-7; accord Tr. 1584-85, 1587.
Distances
    The Government introduced prescription evidence at the hearing to 
show that Trinity II failed to resolve the red flag of customers who 
had allegedly travelled unusually long distances and/or had taken 
suspicious routes for the purpose of obtaining, presenting, and filling 
prescriptions for controlled substances. Specifically, the Government 
introduced evidence exhibiting this red flag with respect to four of 
Trinity II's customers identified in the first charge of the Show Cause 
Order and whose patient records the Government had requested pursuant 
to its December 4, 2014 subpoena.
    For one such customer, S.S., the Government introduced a dispensing 
log, patient profile, and the front and back of prescriptions to 
establish that on June 5, 2013, Trinity II filled a prescription for 
S.S. for 150 tablets of hydromorphone 8 mg, with instructions to take 
one tablet every four hours as needed for breakthrough pain. GX 44, at 
1, 2, 8-9; Tr. 1676-80. Although the front of the prescription did not 
include S.S.'s address,\27\ the other prescription evidence--the fill 
sticker attached to the back of the prescription, the dispensing log, 
and the patient profile--all show S.S.'s address to be in Orange Park, 
Florida, which is a city located near Jacksonville, Florida. GX 44, at 
1, 2, 9; Tr. 1680.
---------------------------------------------------------------------------

    \27\ See GX 44, at 8. The Show Cause Order alleges that Trinity 
II's filling of this prescription also constitutes an independent 
violation of 21 CFR 1306.05, which requires, inter alia, all 
prescriptions for controlled substances to bear the full name and 
address of the patient and imposes a corresponding liability ``upon 
the pharmacist . . . who fills a prescription not prepared in the 
form prescribed by DEA regulations.'' Id. at Sec.  1306.05(a), (f). 
As set forth more fully infra, I agree.
---------------------------------------------------------------------------

    It is undisputed that Trinity II is located in Clearwater, Florida, 
and that both the front of the prescription and Trinity II's dispensing 
log show that the prescribing physician's address was in Tampa, 
Florida. GX 44, at 1, 8. The Government also introduced Google Maps 
evidence showing that S.S. would have traveled: (1) 175 miles from his 
home address to the prescribing physician, (2) about 23 miles from 
there to Trinity II, and then (3) 199 miles from Trinity II back to his 
home address. GX 44, at 4-7; Tr. 1681-83. Indeed, S.S. would have to 
travel across the entire state of Florida--from the Jacksonville area 
on the East Coast of Florida to the greater Tampa Bay area on the West 
Coast of Florida--to obtain and to fill this schedule II prescription. 
Thus, I find that S.S. would have to travel approximately 397 miles 
roundtrip to obtain the June 5, 2013 hydromorphone 8 mg prescription 
from his physician, and that S.S. would have to travel at least 198 
miles after picking up his prescription to return home. See id. I also 
find that Trinity II knew the addresses of both S.S. and his 
prescribing physician. See GX 44, at 1, 2, 8-9. I further find that the 
front of the prescription, the back of the prescription bearing the 
fill sticker, the patient profile, and the dispensing log do not 
reflect any notes or comments explaining why Trinity II filled the 
prescription given the unusual distances S.S. traveled to obtain and to 
fill this prescription. GX 44, at 1, 2, 8-9; accord Tr. 1676-77, 1685, 
2113.
    Although Professor Doering testified that there is no magical 
``distance cutoff'' in determining when a particular distance 
constitutes a red flag, Tr. 1692-93, in response to hypothetical 
questions, he did testify that when a pharmacist in Florida receives a 
prescription for a controlled substance from a customer whose address 
is, for example, 75 miles away, ``[t]he standard of care calls for the 
pharmacist to identify that as a red flag and to initiate steps that 
may resolve that red flag'' and to document any such resolution. Tr. 
2112. He testified that this standard of care ``requires the pharmacist 
to find out the address of where the person resides'' and ``to ask the 
patient for that address information'' by, for instance, ``ask[ing] for 
identification.'' Tr. 2119-20; see also id. at 1684. He further 
testified that in his opinion the distance red flag for this 
prescription should have been identified as part of the drug 
utilization process, and the fact that S.S. also paid cash \28\ raised 
an additional red flag. Tr. 1684, 1686 (``patients paying cash for 
their prescriptions is a recognized red flag''), 1696. As a result, 
Professor Doering testified that filling this prescription was 
inconsistent with Florida's standard of care, that it was not filled in 
the usual course of professional practice, nor filled in the proper 
exercise of the pharmacist's corresponding responsibility. Id. at 1701-
02.\29\
---------------------------------------------------------------------------

    \28\ Trinity II's own dispensing report states that S.S. paid 
``cash'' for the July 5, 2013 prescription, and I find that S.S. did 
indeed pay for this prescription (rather than a third-party payer). 
See GX 44, at 1. The prescription evidence also does not reflect 
that Trinity II ever attempted to resolve the ``paying cash'' red 
flag. Tr. 1686.
    \29\ As discussed infra in the context of cocktail 
prescriptions, on June 27, 2013 and July 23, 2013, Trinity II also 
filled prescriptions for S.S. on each date for carisoprodol 350 mg, 
hydromorphone 8 mg and Xanax 2 mg. GX 44, at 1, 2, 14-19, 22-27; Tr. 
1697-98; 1703-05. I also find that the front of the prescriptions, 
the back of the prescriptions bearing the fill stickers, the patient 
profile, and the dispensing log do not reflect any notes or comments 
whatsoever explaining why Trinity II filled these prescriptions 
given the unusual distances S.S. traveled to obtain and to fill 
these prescriptions. GX 44, at 1, 2, 14-19, 22-27; accord Tr. 1700, 
1705. Professor Doering also testified that filling the June 27, 
2013 and July 23, 2013 prescriptions were inconsistent with 
Florida's standard of care, that they were not filled in the usual 
course of professional practice or in the proper exercise of the 
pharmacist's corresponding responsibility. Tr. 1701, 1705.
---------------------------------------------------------------------------

    For a second customer, D.W., the Government introduced a dispensing 
log, patient profile, and the front and back of prescriptions to 
establish that on March 8, 2012, Trinity II filled two prescriptions 
for D.W.--one for 120 tablets of oxycodone 30 mg with

[[Page 7317]]

ginger \30\ (with instructions to take one capsule four times daily) 
and the other for 30 tablets of carisoprodol 350 mg under the brand 
name Soma (with instructions to take one tablet every night). GX 45, at 
1, 2, 8-11; Tr. 1710, 1713-14.
---------------------------------------------------------------------------

    \30\ Professor Doering testified that physicians will issue a 
prescription calling for compounding with ginger ``to deter one from 
injecting the drug intravenously'' because ginger will ``make it 
sting and burn if someone were to try to inject it intravenously.'' 
Tr. 1265. It is also a deterrent to ``nasal insufflation'' 
(snorting) of the drug because ``it would be [an] irritant to the 
lining of the nasal mucous membranes.'' Id. at 1558.
---------------------------------------------------------------------------

    According to the front of the oxycodone prescription,\31\ the fill 
sticker attached to the back of both prescriptions, the dispensing log, 
and the patient profile, D.W.'s address was in Wellborn, Florida. GX 
45, at 1, 2, 8, 9, 11; Tr. 1708-09. It is undisputed that the front of 
both prescriptions and Trinity II's fill stickers show that the 
prescribing physician's address was in Tampa, Florida. GX 45, at 8-11; 
Tr. 1709-1712. The Government also introduced Google Maps evidence 
showing that D.W. would have traveled: (1) 184 miles from his home 
address to the prescribing physician, (2) about 18 miles from there to 
Trinity II, and then (3) 202 miles from Trinity II back to his home 
address. GX 45, at 4-7.
---------------------------------------------------------------------------

    \31\ The front of the second prescription for Soma did not bear 
the patient's address. See GX 45, at 10.
---------------------------------------------------------------------------

    Thus, I find that D.W. would have to travel approximately 404 miles 
roundtrip to obtain the March 8, 2012 oxycodone and Soma prescriptions 
from his prescribing physician, fill them at Trinity II, and then 
return home. See id. I also find that Trinity II knew the address of 
both D.W. and his prescribing physician. See GX 45, at 1, 2, 8-11. I 
further find that the front of the prescriptions, the back of the 
prescriptions bearing the fill sticker, the patient profile, and the 
dispensing log do not reflect any notes or comments explaining why 
Trinity II filled the prescriptions given the unusual distances D.W. 
traveled to obtain and to fill these prescriptions. GX 45, at 1, 2, 8-
11; accord Tr. 1712.
    Professor Doering testified that in his opinion ``[t]he long 
distance between the patient's home and the doctor's office'' was a red 
flag that was presented by D.W.'s prescriptions and which Trinity II 
should have identified as part of the drug utilization process. Tr. 
1712. As a result, Professor Doering testified that filling these 
prescriptions was inconsistent with Florida's standard of care, that 
they were not filled in the usual course of professional practice, nor 
filled in the proper exercise of the pharmacist's corresponding 
responsibility. Id. at 1712-13.
    On April 5, 2012 and on May 3, 2012, Trinity II also filled 
prescriptions for D.W. for 120 tablets of oxycodone 30 mg with ginger 
each time--with the same instructions and from the same prescribing 
physician as in the March 8, 2012 oxycodone prescription that Trinity 
II had filled for D.W. GX 45, at 1, 2, 12-13, 16-17; Tr. 1714-17. On 
April 19, 2012 and May 11, 2012, Trinity II filled prescriptions for 
D.W. for 30 tablets of Soma 350 mg each time--again, with the same 
instructions and from the prescribing physician as the Soma 
prescription that Trinity II had filled for D.W. on March 8, 2012. GX 
45, at 1, 2, 14-15, 18-19; \32\ Tr. 1716, 1718. As with the March 8, 
2012 prescriptions for oxycodone and Soma, I find that D.W. would have 
traveled approximately 404 miles roundtrip to obtain the April 5, 2012 
and May 3, 2012 oxycodone prescriptions, as well as the April 19, 2012 
and May 11, 2012 Soma prescriptions, from his prescribing physician, 
and that D.W. would have traveled at least 202 miles after picking up 
his prescription to return home. See GX 45, at 4-7. I further find that 
the front of the prescriptions, the back of the prescriptions bearing 
the fill sticker, the patient profile, and the dispensing log do not 
reflect any notes or comments explaining why Trinity II filled the 
prescriptions given the unusual distances D.W. traveled to obtain and 
to fill these prescriptions. GX 45, at 1, 2, 12-19; accord Tr. 1715, 
1717.
---------------------------------------------------------------------------

    \32\ And like the March 8, 2012 Soma prescription to D.W., the 
front of these Soma prescriptions lacked the patient's address. See 
id.
---------------------------------------------------------------------------

    Professor Doering testified that these four prescriptions also 
presented the same unusual distance red flag that Trinity II should 
have identified as part of the drug utilization process. See Tr. 1715-
18. He also testified that, unlike the March 8, 2012 oxycodone and Soma 
prescriptions that Trinity II had filled on the same day, the fact that 
D.W. had to make two separate trips in April and in May to get the same 
prescriptions further emphasized the significance of the distance red 
flag of diversion. See id. at 1716 (``it sort of adds emphasis to that 
long distance thing because that meant two trips instead of one''). As 
a result, Professor Doering testified that filling these prescriptions 
was inconsistent with Florida's standard of care, that they were not 
filled in the usual course of professional practice, nor filled in the 
proper exercise of the pharmacist's corresponding responsibility. Id. 
at 1715-19.
    For a third customer, C.V., the Government introduced a dispensing 
log, patient profile, and the front and back of a prescription to 
establish that on May 10, 2012, Trinity II filled a prescription for 
C.V. for 90 tablets of hydromorphone 8 mg, under the brand name 
Dilaudid, with instructions to take one tablet every eight hours. GX 
46, at 1-2, 7-8; Tr. 1719-21. According to the front of the 
prescription, the fill sticker attached to the back of the 
prescription, the dispensing log, and the patient profile, C.V.'s 
address was in Port Charlotte, Florida. GX 46, at 1-2, 7-8; Tr. 1720-
21. It is undisputed that the front of the prescription and Trinity 
II's fill stickers show that the prescribing physician's address was in 
Tampa, Florida. GX 46, at 7-8; Tr. 1720-21. The Government also 
introduced Google Maps evidence showing that C.V. would have traveled: 
(1) 105 miles from his home address to the prescribing physician, (2) 
about 22 miles from there to Trinity II, and then (3) 97 miles from 
Trinity II back to his home address. GX 46, at 3-6. Thus, I find that 
C.V. would have to travel approximately 224 miles roundtrip to obtain 
the May 10, 2012 prescription from his prescribing physician, fill it 
at Trinity II, and then return to his home. See id. I also find that 
Trinity II knew the address of both C.V. and his prescribing physician, 
and that C.V. paid ``cash'' for the prescription. See GX 46, at 1-2, 7-
8. I further find that the front of the prescription, the back of the 
prescription bearing the fill sticker, the patient profile, and the 
dispensing log do not reflect any notes or comments whatsoever 
explaining why Trinity II filled the prescription given the unusual 
distances C.V. traveled to obtain and to fill this prescription (or the 
fact that C.V. paid ``cash'' to fill it). Id.; accord Tr. 1719, 1722.
    Professor Doering testified that this prescription presents ``the 
distance red flag'' that Trinity II should have identified as part of 
the drug utilization process. See Tr. 1722. As a result, he testified 
that filling this prescription was inconsistent with Florida's standard 
of care, that it was not filled in the usual course of professional 
practice, nor filled in the proper exercise of the pharmacist's 
corresponding responsibility. Id. at 1722-23.
    For a fourth customer, D.E., the Government introduced a dispensing 
log, patient profile, and the front and back of a prescription to 
establish that on June 13, 2013 and on July 3, 2013, Trinity II filled 
two prescriptions for D.E. for 120 tablets of hydromorphone 8 mg for 
each prescription, both under the brand name Dilaudid, with the same

[[Page 7318]]

instructions to take one tablet every six hours for 30 days. GX 48, at 
1-2, 8, 10-11; Tr. 1724-25, 1728. According to the front of the 
prescriptions, the fill stickers attached to the back of the 
prescriptions, the dispensing log, and the patient profile, D.E.'s 
address was in Brooksville, Florida. GX 48, at 1-2, 8; Tr. 1724, 1728-
29. It is undisputed that the front of the prescriptions show that the 
prescribing physician's address was in Tampa, Florida. GX 48, at 8, 10; 
Tr. 1725. The Government also introduced Google Maps evidence showing 
that D.E. would have traveled: (1) 44 miles from his home address to 
the prescribing physician,\33\ (2) about 20 miles from there to Trinity 
II, and then (3) 55 miles from Trinity II back to his home address. GX 
48, at 3-7. Thus, I find that D.E. would have to travel approximately 
119 miles roundtrip to obtain the June 13, 2013 prescription from his 
prescribing physician, fill it at Trinity II, and then return to his 
home. See id. I also find that Trinity II knew the address of both D.E. 
and his prescribing physician, and that D.E. paid ``cash'' for the 
prescription. See GX 46, at 1-2, 8, 10. I further find that the front 
of the prescriptions, the back of the prescriptions bearing the fill 
stickers, the patient profile, and the dispensing log do not reflect 
any notes or comments explaining why Trinity II filled the prescription 
given the unusual distances D.E. traveled to obtain and to fill this 
prescription (or the fact that D.E. paid ``cash'' to fill it). Id.; 
accord Tr. 1727, 1732.
---------------------------------------------------------------------------

    \33\ The street address of the prescribing physician reflected 
on the front of the prescriptions was different from what was shown 
on Trinity II's dispensing report and fill sticker; however, the 
identity and the city (Tampa, Florida) of the physician was the same 
in every address. Compare GX 46, at 1 with id. at 8, 10. Although 
the distance calculation from the same city (Tampa) would have been 
very similar using either Tampa address, I find that the address on 
the prescriptions themselves is the most reliable evidence of the 
prescribing physician's address because it came directly from the 
physician. I find that the calculation of the distances to and from 
D.E.'s prescribing physician--as reflected in the Government's 
Google Maps evidence--is based, appropriately, on the street address 
reflected on the front of the June 13, 2013 and July 3, 2013 
prescriptions. Id. at 4.
---------------------------------------------------------------------------

    Moreover, I find that when Trinity II filled D.E.'s Dilaudid 
prescription on July 3, 2013, Trinity II filled that prescription 
early--yet another red flag. Specifically, D.E.'s prescription that 
Trinity II filled on June 13, 2013 was for 120 tablets of Dilaudid 8 mg 
and instructions for D.E. to take one tablet every six hours for 30 
days. GX 48, at 1-2, 8; Tr. 1729-30. Hence, the 120 pills prescribed to 
be taken at the rate of four pills per day constitute a 30-day supply 
that should have lasted D.E. until at least July 12, 2013. 
Nevertheless, on July 3, 2013, Trinity II filled another prescription 
for another 120 pills of Dilaudid 8 mg with instructions to take one 
tablet every 6 hours for 30 days. GX 48, at 1-2, 10-11; Tr. 1731. Thus, 
I find that when Trinity II filled this second prescription on July 3, 
2013, Trinity II filled it 9 days early. Accord Tr. 1731. I also find 
that the front of these prescriptions, the back of the prescriptions 
bearing the fill stickers, the patient profile, and the dispensing log 
do not reflect any notes or comments explaining why Trinity II filled 
this prescription early. GX 48, at 1-2, 8, 10-11; Tr. 1731-32.
    Professor Doering testified that this prescription presents ``[t]he 
combination of the red flags. It's too early and the distance red 
flag.'' Tr. 1731, 1727 (``the distance is a long ways. Which in the 
judgment of my opinion, the pharmacist, it should raise a red flag.''). 
As a result, he testified that filling these prescriptions was 
inconsistent with Florida's standard of care, that they were not filled 
in the usual course of professional practice, nor filled in the proper 
exercise of the pharmacist's corresponding responsibility. Id. at 1727-
28, 1732.
Cocktail Prescriptions
    The Government introduced prescription evidence at the hearing to 
show that Trinity II failed to resolve the red flag of ``cocktail 
prescriptions,'' which the Government alleged occurs when a customer 
presents multiple prescriptions that would provide the same patient an 
opioid, a benzodiazepine, and a muscle relaxer. Specifically, the 
Government introduced evidence exhibiting this red flag with respect to 
three of Trinity II's customers identified in the first charge of the 
Show Cause Order and whose patient records the Government had requested 
pursuant to its December 4, 2014 subpoena.
    For one such customer, S.S., the Government introduced a dispensing 
log, patient profile, and the front and back of prescriptions to 
establish that on June 27, 2013, Trinity II filled three prescriptions 
issued by the same prescribing physician for him: (1) 150 tablets of 
hydromorphone 8 mg (with instructions to take one tablet ``every 4 
hours as needed [for] breakthrough pain''); (2) 60 tablets of 
carisoprodol 350 mg, under the brand name Soma (with instructions to 
take one tablet ``twice daily as needed''); and (3) 45 tablets of 
alprazolam 2 mg, under the brand name Xanax (with instructions to take 
half of a tablet ``three times daily as needed for anxiety'') . GX 44, 
at 1, 2, 14-19; Tr. 1697-98. On July 23, 2013, Trinity II filled for 
S.S. the same three prescriptions from the same prescribing physician 
for hydromorphone 8 mg, carisoprodol 350 mg, and alprazolam 2 mg in the 
same amounts and with the same dosage instructions as for the June 27, 
2013 prescriptions. GX 44, at 1, 2, 22-27; Tr. 1703-05. Thus, I find 
that the evidence establishes that Trinity II twice (on June 27, 2013 
and on July 23, 2013) filled prescriptions for S.S. for the same 
combination of controlled substances--an opioid (hydromorphone), a 
benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 
44, at 1, 2, 14-19, 22-27. I further find that the front of the 
prescriptions, the back of the prescriptions bearing the fill stickers, 
the patient profile, and the dispensing log do not reflect any notes or 
comments explaining why Trinity II filled this combination, or 
cocktail, of prescriptions. Id.; accord Tr. 1700, 1705.
    For a second customer, J.Ha., the Government introduced a 
dispensing log, patient profile, and the front and back of 
prescriptions to establish that on March 7, 2012, Trinity II filled 
three prescriptions issued by the same prescribing physician for her: 
(1) 120 tablets of oxycodone 30 mg (with instructions to take 1 tablet 
every 6 hours as needed); (2) 30 tablets of carisoprodol 350 mg, under 
the brand name Soma (with instructions to take 1 tablet every night); 
and (3) 30 tablets of alprazolam 2 mg, under the brand name Xanax (with 
instructions to take one tablet daily). GX 73, at 1, 2, 4-9; Tr. 1594-
98. On May 3, 2012 and May 31, 2012, Trinity II filled for J.Ha. 
prescriptions from the same prescribing physician for oxycodone 30 mg, 
carisoprodol 350 mg, and alprazolam 2 mg in the same amounts and with 
the same dosage instructions \34\ as for the March 7, 2012 
prescriptions. GX 73, 1-2, 10-21; Tr. at 1605-12. Thus, I find that the 
evidence establishes that on three separate occasions Trinity II filled 
for J.Ha. prescriptions for the following combination of controlled 
substances--an opioid (oxycodone), a benzodiazepine (alprazolam), and a 
muscle relaxant (carisoprodol). GX 73, at 1, 2, 4-21. I further find 
that the front of the prescriptions, the back of the prescriptions 
bearing the fill stickers, the patient profile, and the dispensing log 
do not reflect any notes or comments explaining why Trinity II filled 
this

[[Page 7319]]

combination, or cocktail, of prescriptions. Id.; accord Tr. 1594, 1597, 
1604, 1608, 1612.
---------------------------------------------------------------------------

    \34\ The fill sticker for the May 31, 2012 oxycodone 30 mg 
prescription for J.Ha. reflected the additional phrase ``for pain'' 
to the otherwise identical instruction that J.Ha. had received on 
the March 7, 2012 and May 3, 2012 prescriptions to take one tablet 
of oxycodone 30 mg every six hours as needed. GX 73, at 17.
---------------------------------------------------------------------------

    For a third customer, R.Ha., the Government introduced a dispensing 
log, patient profile, and the front and back of prescriptions to 
establish that on March 7, 2012, Trinity II filled the following three 
prescriptions issued by the same prescribing physician for him: (1) 180 
tablets of oxycodone 30 mg (with instructions to take one tablet every 
four to six hours as needed); (2) 60 tablets of carisoprodol 350 mg, 
under the brand name Soma (with instructions to take one tablet twice 
daily); and (3) 30 tablets of alprazolam 1 mg, under the brand name 
Xanax (with instructions to take one tablet every night). GX 74, at 1, 
2, 4-9; Tr. 1598-1600. On May 3, 2012 and May 31, 2012, Trinity II 
filled for R.Ha. the same three prescriptions from the same prescribing 
physician for oxycodone 30 mg, carisoprodol 350 mg, and alprazolam 2 mg 
in the same amounts and with the same dosage instructions \35\ as for 
the March 7, 2012 prescriptions. GX 74, 1-2, 10-21; Tr. at 1606-08, 
1611-12. Thus, I find that the evidence establishes that on three 
separate occasions Trinity II filled for R.Ha. prescriptions for the 
following combination of controlled substances--an opioid (oxycodone), 
a benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 
74, at 1, 2, 4-21. I further find that the front of the prescriptions, 
the back of the prescriptions bearing the fill stickers, the patient 
profile, and the dispensing log do not reflect any notes or comments 
explaining why Trinity II filled this combination, or cocktail, of 
prescriptions. Id.; accord Tr. 1597, 1604, 1608, 1612.
---------------------------------------------------------------------------

    \35\ The fill sticker for the May 3, 2012 and May 31 2012 
alprazolam 1 mg prescriptions instructed R.Ha. to take one-half to 1 
tablet every day as needed, which is slightly different from the 
instruction in the March 7, 2012 prescription to take one tablet 
every night. Compare GX 74, at 7 with id. at 13, 19. Professor 
Doering testified that, in his opinion, this was a labeling error. 
Tr. 1601-02.
---------------------------------------------------------------------------

    Professor Doering testified that the combination of these three 
drugs that Trinity II filled for customers like S.S., J.Ha., and R.Ha. 
constituted ``the unholy trinity'' or ``cocktail prescriptions'' that 
present a ``drug-drug interaction'' red flag because they are 
``symbolic of drug interactions that might cause harm to the patient.'' 
Tr. 894-96. He emphasized that this ``combination of drugs'' risks harm 
to the patient because they ``have additive central nervous system 
depressant properties.'' Id. at 1698, see also id. at 1603 (``that's 
also the red flag of the so called accumulative additive effects of 
drugs with CNS depressant properties''). In his opinion, this is a red 
flag that Trinity II should have identified and resolved during the 
drug utilization review process with respect to customers S.S., J.Ha., 
and R.Ha. Id. at 1446, 1448.\36\ As a result, he testified that filling 
these cocktail prescriptions without resolving the drug-drug 
interaction red flag was inconsistent with Florida's standard of care, 
that they were not filled in the usual course of professional practice, 
nor filled in the proper exercise of the pharmacist's corresponding 
responsibility. Id. at 1604-05, 1609, 1612-13, 1701, 1705.
---------------------------------------------------------------------------

    \36\ Professor Doering also testified that the fact that Trinity 
II filled the cocktail prescriptions for S.S. 14 days after the 
prescriptions were issued presented another red flag because 
patients who are legitimately ``in pain and or having symptoms that 
might require these medications[ ] will get the prescriptions filled 
soon after they're written.'' Tr. 1700; compare GX 44, at 14, 16, 18 
(prescriptions dated June 13, 2013) with id. at 15, 17, 19 
(corresponding fill stickers dated June 27, 2013). I find that the 
front of these prescriptions, the back of the prescriptions bearing 
the fill stickers, the patient profile, and the dispensing log do 
not reflect any notes or comments explaining why Trinity II filled 
this combination, or cocktail, of prescriptions 14 days after the 
prescriptions were issued. Id.; accord Tr. 1700.
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Pattern Prescribing to Patients With the Same Last Name and Address
    The Government introduced prescription evidence at the hearing to 
show that Trinity II failed to resolve the red flag of ``pattern 
prescribing'' reflecting a lack of individualized drug therapy, and 
which the Government alleges occurs whenever two related individuals 
present prescriptions issued (1) by the same prescribing physician, (2) 
on the same day, and (3) for the same drugs. Specifically, the 
Government introduced evidence exhibiting this red flag with respect to 
two sets of Trinity II's customers, in which each set of two customers 
shared a last name and home address, and who were also identified in 
the first charge of the Show Cause Order and whose patient records the 
Government had requested pursuant to its December 4, 2014 subpoena.
    For the first set of customers, J.Ha. and R.Ha., and as noted above 
in the ``cocktail prescription'' fact findings, the Government 
introduced dispensing logs, patient profiles, and the front and back of 
prescriptions to establish that on March 7, 2012, May 3, 2012, and May 
31, 2012, J.Ha. and R.Ha. presented and Trinity II filled three 
prescriptions for the same controlled substances on each date: (1) 
Oxycodone, (2) carisoprodol, and (3) alprazolam. GX 73, at 1, 2, 4-21; 
GX 74, 1, 2, 4-21. The same evidence also shows that J.Ha. and R.Ha. 
share the same: (1) Home address in Clearwater, Florida; (2) last name; 
and (3) prescribing physician. Id. As a result, I find that on three 
separate occasions, the same prescribing physician issued prescriptions 
for the same combination of drugs (oxycodone, carisoprodol, and 
alprazolam) to J.Ha. and R.Ha. on the same dates. GX 73, at 1, 2, 4, 6, 
8, 10, 12, 14, 16, 18, 20; GX 74, at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 
20. In addition, I find that on March 7, 2012, May 3, 2012, and May 31, 
2012, Trinity II filled each of these prescriptions even though Trinity 
II knew that they came: (1) From the same prescribing physician; (2) 
for the same combination of drugs; and (3) for patients with the same 
last name and same home address. GX 73, at 1, 2, 5, 7, 9, 11, 13, 15, 
19, 21; GX 74, at 1, 2, 5, 7, 9, 11, 13, 15, 19, 21. I further find 
that the front of the prescriptions, the back of the prescriptions 
bearing the fill stickers, the patient profile, and the dispensing log 
do not reflect any notes or comments explaining why Trinity II 
nonetheless filled these prescriptions. Id.; accord Tr. 1594, 1597, 
1604, 1608, 1612.
    For the second set of customers, M.W. and J.W., the Government 
introduced dispensing logs, patient profiles, and the front and back of 
prescriptions to establish that on November 20, 2013 and on December 
18, 2013, M.W. and J.W. presented and Trinity II filled identical 
prescriptions for 150 capsules of oxycodone 30 mg compounded with 
ginger, with the same dosage instructions to take one capsule every 
four to six hours for pain.\37\ GX 75, at 1, 3, 4-7; GX 76, at 1, 3, 4-
7. The same evidence also shows that M.W. and J.W. share the same: (1) 
Home address in Clearwater, Florida; (2) last name; and (3) prescribing 
physician. Id. As a result, I find that on two separate occasions, the 
same prescribing physician issued prescriptions for the same controlled 
substance (oxycodone) to M.W. and J.W. on November 20, 2013 and on 
December 18, 2013. GX 75, at 1, 3, 4, 6; GX 76, at 1, 3, 4, 6. In 
addition, I find that on those same dates Trinity II filled each of 
these prescriptions, even though Trinity II knew that they came: (1) 
From the same prescribing physician; (2) for the same controlled 
substance; and (3) for patients with the same last name and home 
address. GX 75, at 1, 3, 5, 7; GX 76, at 1, 3, 5, 7. I further find 
that the front of the prescriptions, the back of the prescriptions 
bearing the fill stickers, the patient profile, and the dispensing log 
do not reflect any notes or comments whatsoever explaining why Trinity 
II nonetheless filled these

[[Page 7320]]

prescriptions. Id.; accord Tr. 1616, 1619-21, 1623.
---------------------------------------------------------------------------

    \37\ M.W.'s prescriptions also instructed a ``LIMIT [of] 5 
[capsules] per day.'' GX 75, at 4, 6.
---------------------------------------------------------------------------

    Professor Doering testified that when two patients with the same 
last name and address, like J.Ha. and R.Ha. or M.W. and J.W., present 
prescriptions on the same day from the same prescribing physician for 
the same controlled substance and with the same dosage instructions, 
``it's what some have come to call pattern prescribing.'' Tr. 1602-03; 
see also id. at 1608, 1612, 1620, 1623. In his opinion, this is a red 
flag that Trinity II should have identified and resolved during the 
drug utilization review process ``[b]y contacting the prescriber and/or 
discussing it with the patient'' before filling. See id. at 1603. As a 
result, he testified that filling these prescriptions without resolving 
the pattern prescription red flag was inconsistent with Florida's 
standard of care, that they were not filled in the usual course of 
professional practice, nor filled in the proper exercise of the 
pharmacist's corresponding responsibility. Id. at 1604-05, 1609, 1612-
13, 1620-21, 1623-24.
Controlled Substances Filled Before Authorized Date
    At the hearing, the Government introduced into evidence copies of a 
dispensing log and the front and back of two prescriptions for 
controlled substances that the Government alleged Trinity II twice 
filled for customer D.G. before the date authorized by the prescribing 
physician and in violation of 21 CFR 1306.04(a), 1306.06, 1306.11, and 
21 U.S.C. 829 as set forth in the third and fourth charges of the Show 
Cause Order. For example, the Government introduced a dispensing log 
and the front and back of a prescription dated November 15, 2013 
showing that Trinity II filled a prescription for D.G. on November 20, 
2013 for 7 patches of fentanyl-50 mcg/hr, a schedule II controlled 
substance, under the brand name Duragesic. GX 77, at 1, 6, 7; Tr. 1508-
09, 1513-15. The front of the prescription, however, expressly 
instructed ``NO EXCEPTIONS DO NOT FILL UNTIL 12-06-2013.'' GX 77, at 6; 
Tr. 1514.
    Although the CALJ did not recommend findings of fact related to the 
Government's allegations that Trinity II filled prescriptions early as 
set forth in the first two charges of the Show Cause Order, for this 
(third) charge of the Order, the CALJ did choose to recommend findings 
of fact. Specifically, he recommended that I find that Trinity II 
filled a prescription for a schedule II controlled substance for D.G. 
early because it was filled on November 20, 2013--contrary to the 
prescription's instruction that the prescription not be filled until 
December 6, 2013. R.D. at 48-49. I agree and make this finding of fact.
    Similarly, the Government introduced the front and back of a 
prescription dated December 16, 2013 showing that Trinity II filled a 
prescription for D.G. on December 18, 2013 for 15 patches of fentanyl-
50 mcg/hr under the brand name Duragesic. GX 77, at 8, 9; Tr. 1508-11. 
The Government also introduced a dispensing log showing that Trinity II 
filled the prescription on December 23, 2013. GX 77, at 1; Tr. 1511. 
The front of the prescription, however, expressly instructed ``NO 
EXCEPTIONS DO NOT FILL UNTIL 1-5-2014.'' GX 77, at 8; Tr. 1511-12. The 
CALJ recommended for this (fourth) charge of the Show Cause Order that 
I find that, regardless of whether Trinity II filled this prescription 
on December 18 or December 23, 2013, Trinity II nonetheless filled the 
prescription contrary to the prescribing physician's express 
instruction that the prescription not be filled until January 5, 2014. 
R.D. 48-49, 48 n. 114. I agree and make this finding of fact.
    With respect to these two prescriptions filled by Trinity II, 
Professor Doering testified that filling these prescriptions before the 
date set forth in a ``DO NOT FILL UNTIL'' instruction was inconsistent 
with Florida's standard of care, that they were not filled in the usual 
course of professional practice, nor filled in the proper exercise of 
the pharmacist's corresponding responsibility. Tr. 1512, 1515-16.
Controlled Substances Filled in Stronger Concentration Than Authorized
    At the hearing, the Government introduced into evidence copies of a 
dispensing log, patient profile, and the front and back of seven 
prescriptions for controlled substances that the Government alleged 
Trinity II filled for customer J.T. at dosages that were no less than 
five times stronger than authorized by the prescribing physician and in 
violation of 21 CFR 1306.06 and 1306.11 as set forth in the fifth 
charge of the Show Cause Order. For example, the Government introduced 
the front of a prescription dated July 11, 2013 showing that the 
prescribing physician issued to J.T. a prescription for 20 mg/5 ml of 
morphine liquid, which is a liquid dosage of morphine and a schedule II 
controlled substance, with instructions to take five milliliters every 
six hours for rescue pain. GX 35, at 40; Tr. 1394-96, 1412. However, 
the Government also introduced a dispensing log, patient profile, and 
the back of the same prescription to show that when Trinity II filled 
this prescription for J.T. on July 12, 2012, Trinity II filled the 
prescription for 20 mg/ml of morphine liquid--a concentration that is 
five times stronger than what the prescribing physician had 
authorized--and restating the same dosage directions to take five 
milliliters every six hours for pain. GX 35, at 1, 3, 41; Tr. 1396-98. 
The CALJ recommended that I find that, in fact, on July 12, 2013, 
Trinity II filled a prescription for J.T. for 20 mg/ml that was five 
times stronger than the authorized dosage. R.D. at 50. I agree and make 
this finding of fact.
    The Government also introduced evidence at the hearing showing that 
Trinity II repeatedly filled prescriptions for J.T. for morphine liquid 
at the same concentration (20 mg/ml) that was either five or 15 times 
the prescribed concentration (20 mg/5 ml or 20 mg/15 ml) \38\ on six 
other occasions--August 8, 2012, September 6, 2012, October 3, 2012, 
November 1, 2012, December 27, 2012, and January 25, 2012. GX 35, 1, 3, 
52-53, 58-59, 66-67, 76-77, 84-87. The CALJ recommended that I find 
that, in fact, on each of these occasions Trinity II filled 
prescriptions for J.T. for 20 mg/ml and that this dosage was either 
five times or 15 times stronger than the authorized dosage.\39\ R.D. at 
50. I agree and make these fact findings.
---------------------------------------------------------------------------

    \38\ I agree with the CALJ that the prescribing physician's 
handwriting regarding the dosages for these prescriptions is not 
always clear because they appear to state either 20 mg/5 ml or 20 
mg/15 ml. R.D. at 50. In the Show Cause Order, the Government 
alleged that the dosage for each of these prescriptions were for 20 
mg/5 ml. ALJ Ex. 1b, at 15-16. However, in its Proposed Findings of 
Fact, the Government asked that the Agency find that all the 
prescriptions reflect a dosage instruction of 20 mg/5 ml except for 
the October 3, 2012 and November 1, 2012, prescriptions, which the 
Government claimed reflect a dosage instruction of 20 mg/15 ml. ALJ 
Ex. 40a, at 56-57. In any event, I agree with the CALJ's 
recommendation that for each of these prescriptions, the prescribed 
dosage strengths are either for 20 mg/5 ml or 20 mg/15 ml. R.D. at 
50 n.120.
    \39\ The CALJ also recommended that I find that on November 29, 
2012, Trinity II filled a prescription issued to J.T. for morphine 
liquid for 20 mg/ml when the dosage instruction on the corresponding 
prescription was for 20 mg/5 ml. R.D. at 50 & n.119 (citing GX 35, 
at 1, 80-81). Although this particular prescription was not the 
subject of testimony at the hearing nor included in the Government's 
Proposed Findings of Fact, the Show Cause Order does allege that on 
November 20, 2012, Trinity II received a prescription issued to J.T. 
for 20 mg/5 ml of morphine liquid but nonetheless filled it at the 
dosage strength of 20 mg/ml. ALJ Ex. 1b at 16. The CALJ acknowledged 
that the date in the Show Cause Order (November 20, 2012) does not 
match the date on the fill sticker (November 29, 2012), but he 
recommended this fact-finding anyway and implied that the 
discrepancy was the result of a scrivener's error in the Show Cause 
Order. R.D. at 50 & n.119. Because neither the dispensing log nor 
the patient profile for J.T. show that Trinity II filled any 
prescriptions for J.T. on November 20, 2012 (much less one 
corresponding to the morphine liquid prescription described in the 
Show Cause Order), GX 35, at 1, 3, I find that this mistake in the 
Show Cause Order was merely a scrivener's error. Thus, I agree that 
the Government intended to state in the Order that Trinity II filled 
this prescription on November 29, 2012. And I agree with the CALJ's 
recommendation that I find (and I do so find) that Trinity II filled 
this prescription on November 29, 2012 at a dosage that was five 
times stronger than the prescribing physician had instructed.

---------------------------------------------------------------------------

[[Page 7321]]

    Professor Doering testified that the filling of these prescriptions 
at dosages that were at least ``five times more potent that it was 
supposed to be'' constituted ``a misfill.'' Tr. 1398. ``This issue has 
been communicated to pharmacists. Be careful when you fill liquid 
morphine solutions, because it's a very concentrated form of the 
drug.'' Id. He testified that the issue ``should have been identified 
in the global dispensing process.'' Id. at 1400. He further testified 
that these prescriptions were not filled consistent with the standard 
of care in Florida nor filled in the usual course of pharmacy practice. 
Id. at 1399, 1402, 1404, 1406-07, 1409, 1411-12.
Prescriptions Filled by Pharmacy Interns
    The Government introduced prescription evidence at the hearing for 
the purpose of showing that Trinity II unlawfully allowed pharmacist 
interns, instead of pharmacists, to fill controlled substances 
prescriptions. The Government specifically alleged that Mina A. 
Ghobrial, a pharmacist intern at Trinity II, filled such prescriptions 
based on the presence of the initials ``MAG'' or ``MG'' in the ``filled 
by'' field of the fill stickers. See, e.g., GX 79-82; see also Tr. 339, 
452. The CALJ recommended that I find that the Government failed to 
present evidence to suggest that Ghobrial was not supervised by a 
registered pharmacist. R.D. at 46. I agree and make this finding of 
fact.

Respondent's Case

    Respondent presented the testimony of Mark Abdelmaseeh, a 
pharmacist at Trinity II.\40\ T. 2340-42. Abdelmaseeh testified that he 
worked two days per week as a pharmacist at Trinity II. Id. at 2342. He 
testified that, although technicians and interns worked with the 
pharmacists at Trinity II, pharmacy interns and technicians did not 
dispense any prescriptions. Id. at 2342-43. He further testified that 
his role included ``overlook[ing] and supervis[ing] what's going on in 
the pharmacy'' and ``keep[ing] open communication with the doctors to 
make sure that all prescriptions are legitimate and needed for the 
patient.'' Id. at 2355-56. ``I check to see if there are any 
contraindications or interactions, if the patient has allergies. I look 
to see if the prescription is valid or not. I look to see if the 
prescription is being filled early or not. I look to see if the 
prescription has any mistakes on it, and I call and verify with the 
doctor on every prescription that I fill.'' Id. at 2356.
---------------------------------------------------------------------------

    \40\ Although Respondents presented the testimony of one other 
witness, Kristen Quinette, a former pharmacy technician at Trinity 
I, the CALJ did not consider her testimony in his Recommended 
Decision. After testifying that she had worked at one time at 
Trinity II, the CALJ sustained the Government's objection to her 
testimony since she was not noticed as a witness against Trinity II. 
Tr. 2232, 2247-49.
---------------------------------------------------------------------------

    Abdelmaseeh testified that Trinity II maintains ``records, notes 
and all types of other information other than just the plain 
prescription information'' and that ``[i]t's all documented in the 
computer system.'' Id. at 2345. He specifically testified that Trinity 
II ``maintain[ed] documentation regarding patient allergies'' and 
``interactions with the physicians.'' Id. at 2360-61. He also testified 
that ``[w]hen the customer does pick up the medication they sign off 
for it that they picked up and that they do not have any questions in 
regards to the prescription that was picked up. . . . [a]t the point of 
sale.'' Id. at 2357. Specifically, he testified that the customer signs 
an electronic pad at the register confirming pick up and that the 
customer has no questions for the pharmacist. Id. at 2357-58. He 
further testified that he can access that information ``[a]t the 
register in the computer system.'' Id. at 2359.
    The CALJ noted that Abdelmaseeh has some built-in bias because he 
was still an employee of Trinity II when he testified, giving him 
``some stake in the proceedings.'' R.D. at 34. The CALJ found that this 
bias was reflected in the fact that Abdelmaseeh ``affirmatively and 
deliberately disregarded Respondent's counsel's . . . efforts to elicit 
testimony that stood within the bounds of the in Limine Order when 
there was no question pending in order to provide information that was 
directly the subject of the Government's objections.'' Id. at 34-35. 
The CALJ believed that this was Abdelmaseeh's ``effort to cram in as 
much objectionable testimony as possible'' to get around the terms of 
his in Limine Order. Id. at 35. As a result, the CALJ concluded that 
``it is difficult to afford this witness's testimony the full weight 
that it otherwise might have received in this recommended decision.'' 
Id.
    The CALJ sustained the Government's objections to Respondent's 
attempts to have Abdelmaseeh testify about evidence regarding the 
process the pharmacies used to verify prescriptions and resolve 
concerns, including a description and demonstration of the computer 
software utilized, because such testimony was excluded by the in Limine 
Order. See generally Tr. 2344-66. However, the CALJ nonetheless allowed 
Respondent's counsel to proffer how the witness would have testified on 
that topic. Id. at 2366-2372. Counsel proffered that Trinity II used 
computer software that requires a pharmacist to sign-in and approve 
prescriptions. Id. at 2367. Respondent's counsel also proffered ``that 
the software comes with a particular screen and tab for printing what 
is commonly referred to and has been referred to by Professor Doering 
as a patient profile which includes dispensing history, and it's 
limited to the dispensing history. It's a pre-programmed function of 
that software.'' Id. at 2368, 2370 (``It's an F-11 tab to print a 
profile.''). He also proffered that ``other fields that are maintained 
or other screens that are maintained'' by Trinity II's software 
``include an area for notes on each prescription and that that 
information is maintained at the pharmacy in that . . . software.'' Id. 
at 2369, 2370-71 (``It has a tab for prescription notes, RX notes, and 
it operates not only by the tab but by a function key, F-3, and patient 
information tab that uses a function key, F-4'' and includes ``a date 
and time stamp entry so you can determine on which date those entries 
were made.''). According to counsel, Trinity II's pharmacists ``used 
this software as a mechanism to assist them . . . with identifying red 
flags and then documenting the resolution of those.'' Id. at 2371-72.
    The proffered facts related to Trinity II's computerized record-
keeping and prescription verification process are only relevant to the 
Show Cause Order's first two charges related to the identification and 
resolution of red flags of diversion. The CALJ properly stated that he 
would not consider the proffer as evidence in making his 
recommendation, but he allowed Respondent's counsel to make the proffer 
to preserve the issue for review. See id. at 2352.
    Based principally on this proffer and the Government's failure to 
image Trinity II's computers, Trinity II contends that DEA cannot prove 
that it failed to document resolution of such red flags because ``DEA 
failed to request or obtain Respondent's records where such notes and 
comments were stored.'' Trinity II's Closing Submission and Proposed 
Findings of Fact and

[[Page 7322]]

Conclusions of Law (hereinafter ``Trinity II's Post-Hearing Brief''), 
AJL Ex. 41, at 6. This general argument has some merit (again, assuming 
the proffered facts are true) regarding Trinity II's customers for whom 
the Government never requested ``records where such notes and comments 
were stored.'' Id.
    However, Trinity II's argument does not account for the fact that 
the Government's December 4, 2014 subpoena required Trinity II to 
produce the complete patient profile that Trinity II maintained for 23 
customers as required by Florida Administrative Rule 64B16-27.800, 
entitled ``Requirement for Patient Records.'' GX 98, at 2 (``For each 
of the following patients, please provide a copy of the complete 
patient profile your pharmacy maintained pursuant to Florida 
Administrative Rule 64B16-27.800''). As already noted, this rule 
expressly required Trinity II to maintain in its ``patient record 
system'' a record of every entry ``in the profile record'' for each 
patient for two years, including ``[p]harmacist comments relevant to 
the individual's drug therapy, including any other information peculiar 
to the specific patient or drug.'' ALJ Ex. 38; Fla. Admin. R. 64B16-
27.800. This Rule also mandated that Trinity II ``obtain from the 
patient . . . and shall record'' patient information ``which may relate 
to prospective drug review. The pharmacist shall record any related 
information indicated by a licensed health care practitioner.'' Id. at 
64B16-27.800(2).
    In short, and as discussed more fully infra, Rule 64B16-27.800 
required Trinity II to maintain patient records that included copies of 
any notes and comments reflecting their pharmacists' resolution of any 
red flags of diversion. I find that when the Government requested the 
complete patient profile Trinity II maintained pursuant to Rule 64B16-
27.800 related to the 23 customers in the December 4, 2014 subpoena, 
the Government did in fact request all patient records maintained by 
Trinity II for those customers pursuant to that Rule--including the 
pharmacists' notes and comments for those customers. Thus, I reject 
Trinity II's contention that the Government failed to request records 
including Trinity II's notes and comments.\41\
---------------------------------------------------------------------------

    \41\ And it is also for this reason that I have limited my fact 
findings, supra, regarding the Show Cause Order's first two charges 
relating to violations of Trinity II's corresponding responsibility 
to allegations involving those 23 patients.
---------------------------------------------------------------------------

    Most significantly, Respondent's counsel never stated in his 
proffer that Trinity II did in fact maintain notes and comments 
resolving the alleged red flags for the 23 customers whose records were 
subpoenaed in this case. Although it is possible that Trinity II 
deliberately withheld this evidence in response to the December 4, 2014 
subpoena,\42\ I find that it is more likely than not that, in fact, 
Trinity II failed to produce notes and comments reflecting Trinity II's 
resolution of the red flags in response to the Government's subpoena 
because Trinity II did not actually resolve them and hence had no notes 
or comments reflecting any such resolution. Respondent's counsel was 
careful never to aver during cross-examination of the Government's 
witnesses that Trinity II actually had notes or comments regarding the 
23 patients identified in the subpoena. The CALJ gave Respondent's 
counsel's more than enough latitude to make this claim during his 
proffer or during cross-examination, yet he chose not to do so. 
Respondent's counsel also chose not to impeach Government witnesses 
during cross-examination by using actual notes and comments (or any 
other information) reflecting Trinity II's resolution of red flags for 
any customer discussed at the hearing. Although the in Limine Order 
precluded Trinity II from, inter alia, offering such information as 
evidence in its case-in-chief (ALJ Ex. 29, at 3), nothing in that Order 
precluded Trinity II from using this information to impeach the 
Government's witnesses.\43\ Indeed, it was in Trinity II's self-
interest to use such notes and comments (if they existed) during cross-
examination of the Government's witnesses because it would have been an 
effective way to impeach Government witnesses' testimony that they saw 
no evidence that Trinity II resolved any red flags of diversion. It 
would be a remarkable oversight for Respondent's counsel not to use 
such information during cross-examination if it did exist. As already 
noted, I find that it did not.\44\
---------------------------------------------------------------------------

    \42\ During Respondent's counsel's cross-examination of 
Professor Doering regarding the scope of the Government's December 
4, 2014 subpoena request for 23 customers' patient profiles 
maintained pursuant to Rule 64B16-27.800, Respondent's counsel asked 
``Is the word `profile' anywhere in that Florida administrative code 
provision?'' (Tr. 2174), expecting the witness to confirm counsel's 
own understanding regarding the rule. Professor Doering then 
validated that (mis)understanding by stating that the word 
``profile'' ``does not appear'' to him as he quickly read the rule 
on the stand. Tr. 2176. This reading, of course, is incorrect--Rule 
64B16-27.800(3) expressly references patient profiles. Government 
counsel immediately corrected this error on re-direct by asking 
Professor Doering to read that provision into the record: ``A 
patient record shall be maintained for a period of not less than two 
years from the date of the last entry in the profile record. This 
record may be a hard copy or a computerized form.'' Tr. 2207 
(emphasis added). Although this exchange raises the possibility that 
Respondent's counsel advised his clients not to produce the notes 
and comments regarding the 23 customers referenced in the subpoena 
based on this misunderstanding of the rule, I find (for the reasons 
set forth in the text above) that it is more likely than not that 
Trinity II did not produce any notes or comments regarding these 
customers because they do not exist.
    \43\ In fact, the CALJ lacks the authority to preclude a 
respondent from using relevant information to impeach a witness 
during cross-examination. See Farmacia Yani, 80 FR 29053, 29063 n.25 
(2015) (finding that it was prejudicial error to preclude a 
respondent from using a document to impeach a witness on cross-
examination, even where respondent had failed to present the 
document to the Government in advance of the hearing). Moreover, the 
APA and our regulations preserve a respondent's right to present 
information on cross-examination for the purpose of impeaching the 
Government's witnesses. See 5 U.S.C. 556(d) (``A party is entitled . 
. . to conduct such cross-examination as may be required for a full 
and true disclosure of the facts.''); 21 CFR 1316.60.
    \44\ For the same reason, I reject Trinity II's Exception that 
the CALJ's in Limine Order ``did not permit the Respondents to 
present relevant evidence to the charges set forth in the show cause 
order. As a result, the Respondents were limited in their ability to 
explain the computer system used by the Respondents, which would 
have clarified the record keeping questions.'' Respondents Trinity 
Pharmacy (I)'s and Trinity Pharmacy (II)'s Exceptions to the 
Recommended Decision of the Administrative Law Judge (``Resp. 
Except.''), at 7. Although the CALJ did limit Trinity II's ability 
to present evidence as part of its case-in-chief, as already noted, 
the CALJ (1) gave Trinity II multiple opportunities to comply with 
his prehearing orders, (2) did not (and could not) limit its ability 
to present information during cross-examination of the Government's 
witnesses, and (3) even gave Trinity II the opportunity to provide 
an attorney proffer at the hearing in which Trinity II's counsel 
could have at least proffered facts which, if true, would have 
rebutted the Government's case. Again, as already noted, Trinity II 
chose not to do so. Accordingly, I find that the CALJ acted within 
his discretion when he issued his in Limine Order and denied Trinity 
II's reconsideration motion, and I reject Trinity II's Exception to 
the CALJ's in Limine Order.
     Trinity II also raised in this Exception that the CALJ's in 
Limine Order precluded it from introducing evidence that ``would 
have corroborated Kristen Quinette that pharmacy technicians were 
not permitted to dispense prescriptions.'' Id. at 7. None of the 
allegations in the Show Cause Order relate to pharmacy technicians, 
and the CALJ limited her testimony's relevance to Trinity I. R.D. at 
33 n. 86. In any event, and assuming Trinity II intended to state in 
its Exceptions that it would provide testimony related to pharmacy 
interns, I find that this Exception is moot because I find infra for 
Trinity II on the charges related to pharmacy interns.
---------------------------------------------------------------------------

Discussion

    Before proceeding to analyze the evidence under the public interest 
factors, it is necessary to review the CALJ's discussion of two issues 
raised in the Government's Exceptions to the CALJ's Recommended 
Decision: (1) Whether the Government should have provided DEA-6s to 
Respondent that DEA had provided to its expert and (2) whether the 
expert's testimony was sufficiently ``reliable'' under the 
Administrative Procedure Act (``APA'')

[[Page 7323]]

to be given weight in my decision. See ``Government Exceptions'' 
(hereinafter ``Gov. Except.'') at 13-54.

Requirement To Produce Documents Relied Upon by the Expert

    In his Recommendation, the CALJ included a discussion of whether 
the Government should have produced to Respondent copies of a DEA-6 
related to Trinity II that DEA had provided \45\ to the Government's 
expert witness, Professor Doering. R.D. at 27-28, 28 nn. 78-79.\46\ In 
that discussion, the CALJ stated his belief that the DEA's intent in 
providing documents to an expert is relevant to determining whether the 
expert relied upon these documents in forming his opinion. R.D. at 28 
n. 78 (``Like the other documents forwarded by DEA to Professor 
Doering, DEA-6s were furnished to him to assist him in formulating his 
expert opinion on the Government's theory of the case.''), id. at 28 
(``The proposition that the Government would supply DEA-6s (or any 
other form) to an expert with the expectation that those documents 
would play no role `whatsoever' is dubious at best. Professor Doering 
was sent DEA-6s so he would read, analyze, and utilize them in forming 
his expert opinion''). Contrary to the CALJ's belief, the Government's 
purported ``expectation'' that Professor Doering would rely on DEA-6s 
provided to him is both factually unsupported and legally irrelevant to 
the question at bar.
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    \45\ The Government also raised a separate Exception related to 
the CALJ's statement in his Recommended Decision that ``[i]t is 
unfathomable that the Agency counsel would gratuitously release a 
document as closely held by the Agency as a DEA-6 with no 
expectation that it would be used by that person for any purpose.'' 
Govt. Except. at 69 (emphasis omitted) (citing R.D. at 28 n. 78). 
The CALJ failed to indicate where the record indicates that 
Government counsel produced, much less ``gratuitously released,'' a 
DEA-6 to anyone. In fact, the record contradicts the CALJ's 
rendition of the facts. As Trinity II's counsel established during 
cross-examination of the lead DI at the hearing, it was the DIs, not 
``Agency counsel,'' who provided a DEA-6 to Professor Doering.
    [Mr. Sisco:] All right. Would you describe for me all of the 
information that you initially provided to Professor Doering?
    [DI:] I believe we provided photocopies of the original 
prescriptions. I believe a copy of the E-FORCSE, the dispensing 
report. What else? And a copy of one of my 6s.
    Q When you say a 6, you're talking about a DEA-6. It's your 
report of an investigation?
    A Yes.
    Tr. 581-82. Elsewhere in his Recommended Decision, the CALJ 
himself noted and accepted this same testimony. R.D. at 12 
(accepting DI's testimony that he had ``provided . . . a copy of one 
of his DEA-6 forms . . . to Professor Paul Doering, the Government's 
expert witness. Tr. 581, 589-90''). Professor Doering corroborated 
the DI's response during his own testimony on direct and cross-
examination, stating that he received DEA-6s from the DIs who had 
retained him on behalf of DEA and before he had made first contact 
with Government counsel regarding the case. Id. at 855-59, 1783-84, 
1786-89, 1800-01. As the Government observed, ``[e]veryone is 
entitled to his own opinion, but not to his own facts.'' Govt. 
Except. at 1. I expect all the ALJs working for DEA to ensure that 
that the statements in their Recommended Decisions are well-grounded 
in fact, especially before making statements disparaging counsel who 
appear before them.
    \46\ This issue arose when, for the first time at the hearing, 
Respondent requested production of the DEA-6s that the Government 
had provided to its expert. R.D. at 28 n.79; see Tr. 586, 805-07. 
The Government responded at the hearing that Respondent's request 
was untimely because Government counsel had already notified 
Respondent's counsel by letter months before the hearing that DEA 
had previously provided DEA-6s to Professor Doering and that they 
would not be produced pursuant to T.J. McNichol. Tr. 807-08. The 
Government also proffered a copy of the contents of its unsigned 
expert discovery letter at the hearing. Id. The Government 
subsequently raised an Exception seeking a finding that it had 
provided notice to Respondent's counsel prior to the hearing, and 
the Government attached to its Exceptions an affidavit and a copy of 
the signed expert discovery letter addressed to Respondent's counsel 
consistent with its representation at the hearing. Gov. Except. at 
64-69 & Attachment 1. In his Recommendation, the CALJ decided that 
ruling on whether this discovery request was timely was 
``unnecessary'' because ``the Respondent has not sought to develop 
the record regarding the timeliness of the request or even asked for 
the testimony to be stricken as unavailable to constitute 
substantial evidence.'' R.D. at 28 n.79. I agree that Trinity II 
failed to carry its burden to prove that its request for production 
of the DEA-6s was timely. In any event, as discussed infra, I find 
that Professor Doering did not rely on any DEA-6 as the basis for 
his expert opinion, thereby obviating any putative production 
requirement.
---------------------------------------------------------------------------

    As a threshold matter, the record does not support the CALJ's 
statement that DEA expected Professor Doering to rely on the DEA-6s. 
The CALJ's opinion on this supposed expectation is based solely on the 
fact that the Government provided them to him. See R.D. at 27-28. 
However, the Government may provide an expert with any number of 
documents for reasons that have nothing to do with formulating the 
substantive basis of an expert opinion--such as an index or a table of 
contents. In his Recommended Decision, the CALJ failed to indicate 
where in in the almost 2,400-page transcript and more than 90 exhibits 
in the case there are facts establishing that DEA's ``expectation'' was 
that Professor Doering use the DEA-6s ``in formulating his expert 
opinion on the Government's theory of the case.'' Id. at 28 n.78. Thus, 
I find that the mere fact that the DIs provided a DEA-6 to Professor 
Doering regarding Trinity II is insufficient to establish that DEA did 
so with the intent that he rely upon it in forming his opinion.
    More importantly, even if the record did support the CALJ's belief 
that DEA expected Professor Doering to rely on the DEA-6s in forming 
his opinion, it is legally irrelevant to the question of whether the 
Government should have produced the DEA-6s to Trinity II. ``DEA 
precedent has already made clear that where an expert relies on data or 
documents in forming his opinions, the failure of the sponsoring party 
to produce the data or documents denies the other party a meaningful 
opportunity to cross-examine the expert and show that his opinions are 
unfounded'' and ``runs the very substantial risk that the expert's 
conclusions will be rejected.'' \47\ T.J. McNichol, M.D., 77 FR 57133, 
57146 n.18 (2012). Thus, the only fact that matters is whether 
Professor Doering actually relied on the DEA-6 in forming the 
substantive basis for his expert opinion. Accordingly, I find that, as 
a matter of law, the CALJ's unsupported belief that DEA expected 
Professor Doering to rely on the DEA-6s is irrelevant to the question 
of whether the Government was required to produce them to Trinity II 
because that legal question depends solely on whether Professor 
Doering, in fact, relied on the DEA-6 in forming the substantive basis 
for his opinion. See T.J. McNichol, M.D., 77 FR at 57146 n. 18; CBS 
Wholesale, 74 FR at 36749.
---------------------------------------------------------------------------

    \47\ The CALJ cited to an earlier case, CBS Wholesale 
Distributors, 74 FR 36746, 36749 (2009), where the Agency found that 
expert testimony about whether a respondent was selling ``excessive 
quantities of combination ephedrine products'' was unreliable 
because the expert was unable to produce the data on which he, in 
turn, relied in forming his opinion of what the average monthly 
sales figure calculation was for such products. Id. at 28 n.79. 
Notably, nowhere in that case or in T.J. McNichol (or in any other 
case) has the Agency held that the sponsoring party must produce to 
the other party data or documents that had been provided to the 
expert based on the sponsoring party's ``expectation'' that the 
expert would rely on the information. Rather, as already noted, both 
cases set forth the same requirement: The sponsoring party must 
produce to the other party all information upon which the expert 
actually relied in forming the substantive basis for his/her 
opinion.
---------------------------------------------------------------------------

    The CALJ also contends that Professor Doering, in fact, relied on 
the DEA-6s in forming his expert opinion based on his response to the 
following question during direct examination:

    Q . . . What role did [the DEA-6s] play in your forming of the 
opinion as to the dispensings and fillings that you formed the 
opinion on in this case?
    A None whatsoever ultimately. I used the DEA Form 6 as what I 
would call, like a beacon or flashlight to help me understand where 
I might find that documentation, so I could peer upon that with my 
own two eyes, and not have to rely on or depend on other people's 
impressions or thoughts. I never rely on DEA Form 6s, because I 
think it's risky to do that.

Id. at 859-60. The CALJ found that, ``by his own account, [Professor 
Doering] used the investigative reports as a

[[Page 7324]]

framework to examine other potential evidence.'' R.D. at 27. The CALJ 
concluded that this testimony ``leaves little doubt that the DEA-6s 
supplied to Professor Doering constituted underlying data that 
supported his conclusion, his assertions.'' Id. at 28 n.79.
    Once again, the CALJ cites to the wrong legal standard under Agency 
precedent. The test is not whether Professor Doering used the DEA-6s 
``as a beacon or flashlight'' to find other documents that constituted 
underlying data necessary to form his opinion. The question is whether 
Professor Doering, in fact, relied upon the DEA-6s as a substantive 
basis for his expert opinion. See T.J. McNichol, M.D., 77 FR at 57146 
n. 18; CBS Wholesale, 74 FR at 36749. Here, Professor Doering's 
testimony shows that he used the DEA-6 as a table of contents or an 
index ``to help [him] understand where [he] might find that 
documentation'' upon which he ultimately did rely upon in forming his 
opinion--dispensing reports, dispensing logs, copies of individual 
prescriptions, patient profiles, and Google Maps and MapQuest printouts 
of distances. Tr. 860, 862-63. He even went so far as to testify that 
he only used DEA-6s in this limited way so he would ``not have to rely 
on or depend on other people's impressions or thoughts'' reflected by 
or in the DEA-6. Id. at 860 (emphasis added). Simply put, if an expert 
uses a document like an index to ``find'' other ``documentation'' and 
nothing more, then the expert is not relying on that index in forming 
the substantive basis of an expert opinion. As a result, the other 
party could not use that document to show that the expert's opinion was 
unfounded, and the sponsoring party would not be required to produce 
it.
    Here, the above testimony demonstrates that Professor Doering 
relied on dispensing reports, dispensing logs, copies of individual 
prescriptions, patient profiles, and Google Maps and MapQuest printouts 
in forming his opinions, not the DEA-6s that accompanied them. Tr. 860, 
862-63. Accordingly, pursuant to T.J. McNichol and CBS Wholesale, I 
find that the record establishes that Professor Doering did not rely 
upon the DEA-6s in forming his expert opinion in this case, and thus 
the Government had no obligation to produce them to Trinity II.

Expert Opinions Must Be Supported by Reliable, Probative and Reliable 
Evidence

    Under the APA, final agency action imposing a sanction must be 
``supported by and in accordance with the reliable, probative, and 
substantial evidence.'' 5 U.S.C. 556(d). Like other evidence, the 
Agency has also held that an expert's opinion must be ``supported by 
substantial and reliable evidence.'' CBS Wholesale, 74 FR at 36749 
(citing id.). I agree with the CALJ's decision to overrule Trinity II's 
objections in the hearing and in its closing brief to admitting the 
expert testimony of Professor Doering into evidence.\48\ See R.D. at 
15. After the CALJ evaluated ``the weight that should be accorded [to 
Professor Doering's] expert testimony in this matter,'' R.D. at 16 n. 
51, he recommended that I give his testimony no weight because it was, 
in his view, ``insufficiently reliable to form the basis of a sanction 
under the APA.'' Id. at 33 (``To be clear, however, this is not an 
issue of credibility . . . There is no question that the Professor is 
an individual of impressive credentials . . . This aspect of this 
recommended decision addresses only the narrow issue of whether the 
expert opinions he rendered . . . are sufficiently reliable to support 
a sanction.''). Like the CALJ, I too do not need to rely upon Professor 
Doering's expert testimony to find that Trinity II's DEA registration 
must be revoked. However, unlike the CALJ, I do find that his testimony 
was nonetheless reliable under the APA and could have been accorded 
more evidentiary weight in his recommended fact findings.\49\
---------------------------------------------------------------------------

    \48\ Trinity II objected to the admission of Professor Doering's 
expert testimony on the basis that ``[h]e does not currently have a 
license in effect in the State of Florida'' (Tr. 840) based on 
Professor Doering's testimony that his license had fallen into 
delinquent status for a couple of months as of the date of the 
hearing. Id. at 822-23, 1770. He stated that ``when the decks are 
cleared with this matter . . . I will clear up the delinquent status 
of my license, and it will revert to clear and active, before it 
goes to null and void.'' Id. at 844. He stated that this fact had no 
impact on his ability to work at the University of Florida's School 
of Pharmacy because he was only required to maintain an active 
pharmacist's license in one state, and he had an active license in 
North Carolina. Id. at 821-23. Even if Professor Doering had no 
license in any state, however, DEA regulations do not require an 
expert witness to be licensed in the state in which the alleged 
violations occurred, and Agency precedent authorizes ALJ's to admit 
expert testimony even where the expert was not licensed in the state 
where the violations were alleged to have occurred. 21 CFR 
1316.59(b) (``Opinion testimony shall be admitted when the presiding 
officer is satisfied that the witness is properly qualified''); 
Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44093 n.73 (2012) 
(finding that the Government's expert, who was licensed in Ohio but 
not Kentucky was nonetheless permissible and ``generally reliable 
and probative of whether Respondents (and their pharmacists) 
violated their corresponding responsibility''). Thus, the CALJ 
properly accepted Professor Doering ``as an expert in the practice 
of pharmacy in the State of Florida and the standard of care in the 
dispensing of controlled substances in Florida'' based on his 
expertise and the fact that he stays current in this area of 
expertise. Id. at 843; R.D. at 14. For the same reasons, I find that 
the fact that Professor Doering's CV may not have been up-to-date 
regarding the status of his Florida license is an insufficient basis 
to find that his testimony was unreliable. See R.D. at 28-30.
    \49\ The CALJ states that ``the factual findings set forth in 
this recommended decision are entitled to significant deference.'' 
R.D. at 38 (citing Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 
(1951)). However, nowhere does Universal Camera (or the APA) support 
this standard of review for the CALJ's recommended fact findings. 
Rather, it is axiomatic that an ALJ's recommended decisions are 
subject to de novo review by the agency. See 5 U.S.C. 557(b) (``On 
appeal from or review of the initial decision, the agency has all 
the powers which it would have in making the initial decision except 
as it may limit the issues on notice or by rule.''); Universal 
Camera, 340 U.S. at 492, 493 (the ALJ's recommended fact findings 
become part of the administrative record, just ``as the complaint or 
the testimony'' is part of the record, for the Agency's 
consideration), 494 (the APA states ``that an agency which reviews 
an examiner's [e.g., ALJ's] report has `all the powers which it 
would have in making the initial decision''') (quoting 5 U.S.C. 
557(b)); Vineland Fireworks v. ATF, 544 F.3d 509, 514 (3d Cir. 2008) 
(recognizing an agency's authority under the APA to ``exercise[ ] de 
novo review over the ALJ's decision''). ALJs are ``entirely subject 
to the agency on matters of law; they can be reversed by the agency 
on matters of fact, even where demeanor evidence is an important 
factor.'' Antonin Scalia, The ALJ Fiasco--A Reprise, 47 Univ. Chi. 
L. Rev. 57, 62 (1979). See Kay v. FCC, 396 F.3d 1184, 1189 (D.C. 
Cir. 2005) (the agency may disagree with an ALJ's factual findings, 
including credibility determinations); Tom C. Clark, Attorney 
General's Manual on the Administrative Procedure Act 83 (1947) (``In 
making its decision, whether following an initial or recommended 
decision, the agency is in no way bound by the decision of its 
subordinate officer; it retains complete freedom of decision--as 
though it had heard the evidence itself.'').
---------------------------------------------------------------------------

    The CALJ identified six \50\ reasons for his recommendation not to 
rely on Professor Doering's testimony, and the Government filed 
Exceptions in response to each of them. First, the CALJ believed that 
Professor Doering's supposed ``acknowledgment that the opinions he had 
rendered were not `based on sufficient facts or data' critically 
undermines the weight that can be attached to those opinions.'' \51\

[[Page 7325]]

R.D. at 16. Specifically, the CALJ states that Professor Doering ``did 
not have all of the information that was necessary for him to render an 
expert opinion.'' Id. (citing Tr. 2186-87). In its Exceptions, the 
Government responds that a ``careful and thorough review'' of the 
hearing transcript ``shows that the Presiding Officer's \52\ finding is 
a mischaracterization of Professor Doering's testimony.'' Gov. Except. 
at 13. I agree.
---------------------------------------------------------------------------

    \50\ The CALJ raised two other reasons to challenge the expert's 
reliability, one of which was the issue of DEA-6s, which I addressed 
supra. The other related to the CALJ's disagreement with Professor 
Doering on the question of whether an early fill calculation relates 
to when the pharmacist fills the prescription or to when the 
customer ultimately obtains the controlled substance. R.D. at 24-26. 
I find that this is a legal question and not a question of witness 
reliability, and it is one that I address infra.
    \51\ R.D. at 16 (quoting Fed. R. Evid. 702(b)). Although the 
CALJ properly framed the issue of reliability under Sec.  556(d) as 
a question of how much weight to give to Professor Doering's expert 
opinions, the CALJ erroneously resorted to Federal Rule of Evidence 
702 as the lens through which to make this determination. Id. at 14-
15, 16 n.51. The CALJ stated that the ``Agency has long authorized 
resort to the Federal Rules of Evidence `where they do not conflict 
with Agency regulations.'' Id. at 14-15 (citing Rosalind A. Cropper, 
M.D., 66 FR 41040, 41041 (2001)). In Cropper, the Agency expressly 
rejected the ALJ's evidentiary ruling that the Federal Rules of 
Evidence ``generally apply'' to DEA administrative hearings and 
found ``instead that the Federal Rules of Evidence (FRE) do not 
apply directly to these proceedings . . . but may be used for 
guidance, where they do not conflict with agency regulations.'' 66 
FR at 41041 (citing Klinestiver v. Drug Enforcement Administration, 
606 F.2d 1128, 1130 (D.C. Cir. 1979) (holding that ``nothing in 21 
CFR 1316.59(a) requires DEA to limit admissible testimony to that 
which would be acceptable in a jury trial or under the Federal Rules 
of Evidence'')). If the CALJ wished to deny admission of Professor 
Doering's testimony and exclude it from evidence, the APA only 
authorizes exclusion of evidence that is ``irrelevant, immaterial, 
or unduly repetitious.'' 5 U.S.C. 556(d); Klinestiver, 606 F.2d at 
1130 (``The history of [21 CFR 1316.59] convinces us that DEA never 
intended to bind itself to a higher standard of admissibility than 
that prescribed by . . . 5 U.S.C. 556(d)''); Cropper, 66 FR at 41041 
(same) (``The sections governing these proceedings found in 21 Code 
of Federal Regulations contain no references to the FRE; and 21 CFR 
1316.59 . . . requires only that admitted evidence be `competent, 
relevant, material, and not unduly repetitious.'').
    Although Rule 702 does use the words ``expert'' and 
``reliable,'' that does not make the rule applicable here, even as 
guidance, to determine how much weight to give expert testimony. The 
CALJ concedes that Rule 702 only provides conditions for ``the 
admission of expert opinion testimony.'' R.D. at 15. Indeed, Rule 
702 says nothing about how much weight to give an expert's opinion 
once it has been admitted. For this reason, the Agency adopted the 
CALJ's evidentiary recommendation in Howard N. Robinson, M.D., 79 FR 
19356, 19361 n.39 (2014), to overrule the Government's objection 
based on Rule 702 to receiving an expert witness because ``the 
nature of the objection was framed entirely as an argument as to 
weight and raised no appreciable issue regarding the qualifications 
of the witness to present expert testimony.'' Here, and as already 
noted, the CALJ properly accepted admission of Professor Doering's 
expert opinion (Tr. 843-44) but gave it no weight because it was, in 
the CALJ's view, insufficiently reliable. Thus, Rule 702 has no 
bearing, and provides no guidance, on the question of how much 
weight the expert's testimony should receive.
    \52\ ``The term presiding officer means an administrative law 
judge qualified and appointed as provided in the'' APA. 21 CFR 
1316.42(f) (citing 5 U.S.C. 556). The APA, in turn, characterizes an 
ALJ as a ``presiding or participating employee'' of the Agency. 5 
U.S.C. 556(b). In this case, the presiding officer or employee of 
the Agency was the CALJ.
---------------------------------------------------------------------------

    During the portion of cross-examination cited by the CALJ, it is 
clear that when Professor Doering testified that he ``d[id]n't know 
that [he'd] been provided enough information . . . to render'' expert 
opinions under the Florida standard of care regarding Trinity II's 
resolution of red flags was limited to prescriptions and customers 
where he did not have a corresponding patient profile. Tr. 2186-87, 
2187; accord Gov. Except. 14-15. The record is clear that Professor 
Doering testified that he did have sufficient information to render 
expert opinions related to the Government's charges pursuant to 21 CFR 
1306.04(a) for the 23 patients that were the subject of the December 4, 
2014 administrative subpoena and for whom he had the corresponding 
patient profile. See Tr. 1054-55, 2217, 2224.\53\ For this reason, and 
as noted supra, those are the only patients whose prescription evidence 
I have considered in evaluating the Government's charges pursuant to 21 
CFR 1306.04(a). Accordingly, I reject the CALJ's recommended finding 
that Professor Doering lacked sufficient facts to render his opinions 
with respect to those patients.
---------------------------------------------------------------------------

    \53\ After reviewing prescription evidence and patient profiles 
for over 20 of Respondents' customers and testifying that he saw no 
notes or comments resolving red flags of diversion with respect to 
those customers, Professor Doering was asked ``How many more did you 
need to be able to see to determine whether or not [Respondents] 
kept the notes and comments?'' Tr. 2217. He responded: ``Well, 
technically speaking I'd have to look at each and every one to be 
sure that they exist. I think the logical conclusion is these 
profiles typically don't have such a section.'' Id. On this basis, 
the Government argues that a reasonable inference could be made that 
Trinity II never documented resolution of red flags of diversion--
even for customers for whom patient profiles were not produced. 
Govt. Except. at 17 & n.5. I need not make this inference here 
because, as set forth infra, the prescription evidence and patient 
profiles that are already part of the record in this case are more 
than sufficient to establish by a preponderance of the evidence that 
Trinity II violated its corresponding responsibility pursuant to 21 
CFR 1306.04(a).
---------------------------------------------------------------------------

    Second, the CALJ believed that Professor Doering's expert opinions 
were not reliable because he had not ``reliably applied'' the relevant 
principles and methods to the facts of the case, particularly in the 
context of what constitutes a ``red flag.'' R.D. at 16-17. The CALJ 
stated that ``nothing in his definition of a `red flag' suggests that 
it is an indicator of an elevated risk of diversion, or what, if any, 
steps are required prior to dispensing when a red flag is present.'' 
Id. at 17 (citing Tr. 865). As a threshold matter, how Professor 
Doering, or any other expert, defines a red flag is irrelevant. It is 
the Agency, not an expert, that must decide whether facts in a 
particular case demonstrate that a pharmacist knowingly filled a 
prescription that was not issued for a legitimate medical purpose 
pursuant to 21 CFR 1306.04(a). In this context, the role of the expert 
is merely to render an opinion of whether a pharmacist's decision to 
fill a particular prescription given the facts of the case satisfied 
the state's standard of pharmacy practice--one of several factors the 
Agency can consider in determining whether a pharmacy violated its 
corresponding responsibility. And as already noted, the CALJ chose not 
to make any recommended fact findings related to the Government's 
charges that Trinity II violated its corresponding responsibility.
    In any event, the CALJ's characterization of Professor Doering's 
definition of red flags is at odds with Professor Doering's actual 
testimony. As noted supra, Professor Doering testified that a red flag 
is ``a term that's come to be used to give examples to pharmacies of 
things that might indicate or suggest that prescriptions were filled 
outside the usual course of pharmacy practice.'' Tr. 864. He also 
testified that a red flag ``could be indicative of abuse or misuse,'' 
``over or under compliance,'' ``drug-drug interactions,'' or a 
``forged'' or ``altered'' prescription. Id. at 869. All of these 
indicators reflect what the CALJ described as ``an elevated risk of 
diversion.'' Indeed, Professor Doering's testimony about red flags of 
diversion that pharmacists must look for was consistent with what the 
relevant Florida Administrative Rule requires pharmacists to look for 
as part of their prospective drug use review. See Florida 
Administrative Code Rule 64B16-27.810. In one example, he testified 
that red flags indicating ``over-utilization'' of a controlled 
substance ``touches upon some of the other issues, which means clinical 
use or abuse, or diversion to some other use.'' Tr. 885-86. ``Over[-
]utilization'' ``might be distributing it to other persons'' (i.e., 
diversion to others) or ``taking too much of it.'' Id. at 872. Thus, 
Professor Doering testified that the red flags can indicate both an 
increased risk of diversion to others, but also a risk of clinical 
abuse. As I noted supra, he testified about many examples of red flags 
of diversion in a wide variety of contexts, including those set forth 
in Rule 64B16-27.810. See Gov. Except. at 18-23.
    Also, as already noted, and contrary to the CALJ's 
characterization, Professor Doering repeatedly testified about what 
pharmacists should do when a red flag is present. For example, he 
testified that, ``before filling any prescription'' as part of the 
``prospective drug utilization review, or prospective drug use 
review,'' pharmacists must resolve the red flags and document such 
resolution ``on the face of the prescription, on the rear of the 
prescription, or in the patient profile.'' E.g., id. at 882, 870-73, 
881-83, 958-59.\54\ Most importantly, this

[[Page 7326]]

testimony is consistent with the Florida Administrative Rules that also 
require resolving red flags and documenting resolution of red flags, 
which Professor Doering also discussed at length. See Florida 
Administrative Code Rule 64B16-27.800; Tr. 870-71, 873-75, 881-82, 887-
89, 891, 895-96, 953-55, 957-59, 1015-16, 1169-70, 1353, 1419-20. The 
fact that his testimony closely tracks the Florida Administrative Rules 
supports, rather than undermines, the reliability of his expert 
opinion. As a result, I reject the CALJ's belief that (1) the expert's 
definition of a red flag is relevant and (2) in any event, that the 
expert failed to define a red flag as an indicator of an elevated risk 
of diversion and set forth the steps a pharmacist must follow prior to 
filling or dispensing.
---------------------------------------------------------------------------

    \54\ As the Government notes in its Exceptions, Professor 
Doering testified at length about the steps that a pharmacist must 
follow before filling a controlled substance prescription presenting 
a red flag of diversion. Govt. Except. at 25-26. He testified that 
resolving the red flag during ``[d]rug utilization review means 
using the knowledge, skill, judgment, and experience of the 
pharmacist to evaluate all the information that might be in front of 
them regarding the use of this particular prescription, under this 
particular prescription, in this particular patient.'' Tr. 870-71. 
He testified that this review ``would mean consulting the patient 
profile, which might have a list of other drugs that a patient may 
be on[,] . . . a list of allergies or other adverse effects that 
patients may have had from the drug. It may have other 
idiosyncrasies[,] . . . [it] might have important demographic 
information, such as [an] address . . . information indicating other 
doctors, who may have or are seeing this very patient. It would also 
have information on dates of fills or refills, looking for . . . 
perhaps over[-]utilization of the medication.'' Id. at 871. He also 
testified that pharmacists should resolve red flags by reviewing the 
notes and comments field of the patient profile, consulting with the 
patient and/or the prescribing physician, and consulting Florida's 
Prescription Drug Monitoring Program, ``E-FORCSE.'' Id. at 873-74, 
887-89, 895-96, 953-55, 957, 1015-16, 1419-20.
---------------------------------------------------------------------------

    Third, the CALJ stated that Professor Doering was unreliable 
because the CALJ believed that Professor Doering stated that ``it is 
the (presumably subjective) judgment of each individual pharmacist that 
governs whether a red flag is adequately resolved.'' R.D. at 17. Aside 
from the fact that the transcript fails to reflect Professor Doering 
making this statement,\55\ the CALJ confuses the question of whose 
judgment should be used in filling a prescription with the question of 
whether Trinity II's pharmacists' decisions to fill certain 
prescriptions satisfied their corresponding responsibility.\56\ The 
notion that pharmacists must use their professional judgement when 
filling prescriptions is neither new nor remarkable. Agency precedent, 
federal law, and Florida law uniformly require pharmacists to use their 
professional judgment in deciding whether to fill a prescription and 
dispense controlled substances.\57\ Accordingly, I reject the CALJ's 
view that Professor Doering's testimony was unreliable simply because 
he testified that pharmacists must use their professional judgment--a 
statement that is consistent with Agency precedent.\58\
---------------------------------------------------------------------------

    \55\ As the Government states, ``[t]he Presiding Officer simply 
read the word `subjective' into Professor Doering's testimony when 
it did not exist.'' Govt. Except. at 27.
    \56\ On the latter question, the CALJ also expressed confusion 
about whether Professor Doering was ``speaking from the shoes of the 
pharmacists'' or from his view of ``looking from the shoes of the 
expert'' in determining what the Florida standard of practice should 
be in resolving red flags. R.D. at 17 (quoting Tr. 881). However, 
the record is clear that Professor Doering testified that his 
opinion was that Florida law applicable to all pharmacists governs 
whether a pharmacist adequately resolved a red flag before filling a 
prescription. See, e.g., Tr. 868-79.
    \57\ See, e.g., Ralph J. Bertolino, 55 FR 4,729, 4,730 (1990) 
(``The statutory scheme plainly requires that pharmacists use common 
sense and professional judgment. Where [pharmacists'] suspicions are 
aroused as reasonable professionals . . . pharmacists are called 
upon to obey the law and refuse to dispense.''); id. (``When 
[pharmacists'] suspicions are aroused as reasonable professionals,'' 
they must at least verify the prescription's propriety, and if not 
satisfied by the answer they must ``refuse to dispense''); Medicine 
Shoppe-Jonesborough, 300 Fed. Appx. 409, 412 (6th Cir. 2008) (same) 
(quoting Bertolino); United States v. Hayes, 595 F.2d 258, 261 (5th 
Cir. 1979) (``What is required by [a pharmacist] is the 
responsibility not to fill an order that purports to be a 
prescription but is not a prescription within the meaning of the 
statute because he knows that the issuing practitioner issued it 
outside the scope of medical practice''); Florida Bd. of Pharm. R. 
64B16-27.810 (requiring a pharmacist ``upon recognizing any of the 
[issues]'' to ``take appropriate steps to avoid or resolve the 
potential problems which shall, if necessary, include consultation 
with the prescriber'').
    \58\ In its Exceptions, the Government also notes that ``the 
Presiding Officer's finding is largely immaterial in this case 
because the evidence established that Respondents' pharmacists did 
not exercise any judgment at all with respect to the prescriptions 
containing red flag(s).'' Govt. Except. at 29. Given that I have 
already found facts establishing that Trinity II failed to document 
or otherwise establish that its pharmacists resolved red flags of 
diversion before filling prescriptions, see infra, the Government's 
point is well-taken.
---------------------------------------------------------------------------

    Fourth, the CALJ stated his belief that ``Professor Doering's 
reliance upon the subjective judgment of individual pharmacists as a 
Florida state standard'' undermined the reliability of his testimony. 
R.D. at 19. The CALJ contended that Professor Doering ``conceded that 
pharmacists in Florida can and do disagree on whether particular red 
flags are resolvable,\59\ when a refill constitutes an `early refill,' 
when duplicative therapy is present, and whether a particular 
combination of medications constitutes a `drug cocktail.' '' Id. 
(citing Tr. 1828-29, 1967). This largely academic testimony (during 
cross-examination) about how reasonable pharmacists may differ on where 
to draw the line regarding certain red flags in the abstract is 
interesting but not relevant to the question that Professor Doering was 
actually called on as an expert to answer: Whether prescriptions like 
the ones in this case presented red flags of diversion.
---------------------------------------------------------------------------

    \59\ See also R.D. at 26-27. The CALJ's concern regarding 
Professor Doering's testimony about ``whether particular red flags 
are resolvable'' is particularly irrelevant where, as here, I have 
limited my fact findings to customers where the Government 
established by a preponderance of the evidence that Trinity II 
failed to document that it resolved any red flags of diversion.
---------------------------------------------------------------------------

    And regarding prescriptions like those in this case, Professor 
Doering's testimony about what the standard of practice for Florida 
pharmacists was regarding early fills, duplicative therapy, and ``drug 
cocktails'' was clear. For example, Professor Doering testified that 
``early fills'' or ``early refills'' are red flags of over-utilization, 
and that when there is a fill or refill was more than 2-3 days early, 
that ``early fill'' or ``early refill'' would be a red flag. See Tr. 
989-991, 992 (``when there is a pattern of early refills, it makes one 
very concerned that there is over-utilization''), 1009. Although 
reasonable pharmacists in Florida may disagree whether the line should 
be drawn at two or three days, those are not the early fills in this 
case. In this vein, Professor Doering testified that pharmacists would 
not disagree that prescriptions filled or refilled eight to 17 days 
early, as the prescription evidence shows Trinity II routinely did, 
were red flags of diversion that pharmacists in Florida must resolve 
before filling. E.g., Tr. 1004-05, 2106-2110.
    Professor Doering also testified that there would be no 
disagreement among reasonable pharmacists that when a patient 
simultaneously presents prescriptions for the ``drug cocktail'' of an 
opioid, a benzodiazepine, and a muscle relaxant, then this is a red 
flag that a Florida pharmacist must resolve. Id. at 2111. Likewise, he 
testified that when the same customer simultaneously presents two 
prescriptions for different immediate-release opioids with the same or 
similar instructions, this too is a red flag of duplicative therapy 
that a pharmacist must resolve before filling. Id. Notably, Professor 
Doering's testimony is consistent with the same standard of care 
requirements set forth in Florida Administrative Rule 64B16-27.810--a 
fact that bolsters the reliability of his expert opinion. See ALJ Ex. 
38. Accordingly, I reject the CALJ's belief that Professor Doering's 
testimony about the prescriptions in this case was unreliable.
    Fifth, the CALJ found Professor Doering's testimony unreliable 
because he failed to take into account the ``E-

[[Page 7327]]

FORSCE'' printouts that the DIs had provided to him before rendering 
his opinions. R.D. at 22 (``although he testified that checking E-
FORSCE is a necessary step in the process for the pharmacist, he 
rendered his opinions without taking into consideration any E-FORSCE 
printouts that were provided to him'' and would ``arguably have been 
relevant in reaching a determination as whether a bona fide red flag 
was actually present''). While the CALJ contends that E-FORSCE 
printouts for specific Trinity II customers would have ``arguably'' 
been relevant in identifying a red flag,\60\ the CALJ failed to 
identify any prescription in this case where it would have been 
relevant to identifying a red flag.\61\
---------------------------------------------------------------------------

    \60\ The CALJ concedes that ``this aspect of the case certainly 
has no impact on whether the pharmacists' attempts at red flag 
resolution were adequately documented.'' R.D. at 22. In that vein, 
the Government observed that ``the issue the Presiding Officer 
should have focused on was the fact that Respondents' pharmacists 
were not checking E-FORSCE to resolve the red flags that were seen 
in the prescriptions themselves (as well as the patient profiles and 
dispensing reports), as evidenced by the lack of any documentation 
on the prescriptions and the patient profiles of E-FORSCE queries.'' 
Govt. Except. at 40 n.9.
    \61\ Indeed, even if Professor Doering had received E-FORSCE 
printouts for specific Trinity II customers, they would not have 
rendered red flags presented by the actual prescriptions less 
suspicious. On the contrary, if anything, they may have shown 
additional red flags--such as doctor-shopping--that may not have 
been presented by the prescription evidence already in the case.
---------------------------------------------------------------------------

    Moreover, the Government noted in its Exceptions that the CALJ 
failed to point out that Professor Doering never received E-FORSCE 
printouts for specific Trinity II customers--the printouts the CALJ 
opined would have been relevant to his opinions. Gov. Except. at 39; 
Tr. 553 (DI testified that he ``did not run a specific [E-FORSCE] query 
for each patient''). Instead, the DIs only provided Professor Doering 
with E-FORSCE printouts of the prescriptions filled by Trinity II, 
which was already reflected in (and hence redundant to) Trinity II's 
own prescriptions, dispensing reports, and patient profile. See Tr. 605 
(DI testifying that ``[w]e try not to use E-FORSCE, we prefer to use 
the dispensing report because it's a more accurate reflection of the 
pharmacies. Because it's their records. It's what they have in their 
system.''). Thus, I reject the CALJ's belief that Professor Doering's 
failure to take into account the E-FORSCE printouts of the 
prescriptions filled by Trinity II made his testimony unreliable. He 
correctly based his opinions, instead, on the prescriptions, dispensing 
reports, and patient profiles on which those E-FORSCE printouts depend.
    Sixth, the Government objected to the CALJ's belief that Professor 
Doering was unreliable because ``he was consistently unable to 
accurately calculate the number of days between two filled 
prescriptions, even though supplied on the witness stand with a 
calendar, a pad, a pencil, as much time as he needed, and repeated 
prompting and re-prompting by the Government.'' R.D. at 23. Even 
assuming, arguendo, that the CALJ's belief is correct, the CALJ failed 
to explain why it has any bearing on whether Professor Doering's expert 
opinions are reliable. Professor Doering testified that his trouble in 
making these calculation by hand, on the stand, stems from the fact 
that today's pharmacists rely on a computer to make them automatically. 
Tr. 1368.\62\ More importantly, the calculation of ``the number of days 
between two filled prescriptions'' is a question of fact, not of expert 
opinion.\63\ Thus, even if Professor Doering had little trouble making 
these calculations, it would not have obviated the Agency's independent 
requirement to make or to verify them as fact. Cf. Gov. Except. at 40 
(``the Administrator does not even need Professor Doering's 
calculations to ascertain whether the prescriptions were early''). As 
already noted, the CALJ failed to make any recommended fact findings 
regarding the early fill allegations in this case, much less findings 
that conflicted with those made by Professor Doering. Thus, I reject 
the CALJ's belief that Professor Doering was unreliable based on his 
early fill calculations at the hearing.
---------------------------------------------------------------------------

    \62\ The following exchange at the hearing makes this point 
clear:
    Judge Mulrooney: . . . Would you say that it's difficult to 
count up these days as a pharmacist, particularly if you're in a 
busy retail pharmacy?
    [Professor Doering]: It's not difficult at all. Number 1, the 
computer does it for you. Number 2, they're not under the bright 
lights, under the stress of what I am. Although I may appear to be 
calm and cool, this is a stressful thing for me.
    Tr. 1368. At this point, Professor Doering had already been 
testifying continuously for almost two days.
     In addition to the pressure of testifying on the stand, 
Professor Doering appeared to suffer from witness fatigue, having 
testified for several days in a row in response to a similar pattern 
of questions during direct examination over and over again. For this 
reason, it is not surprising that this fatigue caused him to 
misstate whether he had certain documents in one instance, and to 
respond in ``automatic mode'' in another instance. See R.D. at 30-
33. It is not uncommon for a witness who testifies for most of 5 
days (as reflected in more than 1,400 pages of an almost 2,400-page 
transcript) to make an accidental misstatement. While the CALJ could 
reasonably find particular erroneous testimony unreliable based on 
such mistakes, it would not be reasonable to find the entirety of 
Professor Doering's testimony unreliable under the APA on this 
basis.
    \63\ In its Exceptions, the Government further noted that the 
fact that Professor Doering needed more than one attempt to make a 
particular calculation in the examples cited by the CALJ (R.D. at 
23-24) does not change the Government's allegation that the 
prescriptions at issue ``were extremely early, in most instances 
anywhere from 8 to 15 days early, and Professor Doering reliably 
testified that they were each early.'' Govt. Except. at 40. I agree, 
and as I note infra, what is important is the fact that most (if not 
all) of the relevant fills and refills are so early that Trinity II 
should have resolved these red flags before filling the 
prescriptions.
---------------------------------------------------------------------------

    Finally, Trinity II contends that if the Agency were to find 
Professor Doering unreliable in this case, then it would call into 
question the CALJ's previous finding in Holiday CVS that his consistent 
expert testimony there was reliable and accorded evidentiary weight. 
E.g., ALJ Ex. 41, at 20 (``Holiday CVS and its progeny all find their 
basis in the testimony of Doering.''), 20 n.5 (``[I]n the event the 
Court finds Doering's testimony to be not credible or appropriate to 
rely upon, it likewise calls into question the validity of Holiday CVS 
due to its reliance on his testimony. The effect would be akin to 
removing a bottom floor card in a house of cards.'').\64\ In response, 
the CALJ states that the ``Agency's legal conclusions in its prior 
final orders stand unaffected by a decision regarding the weight that 
should be accorded expert testimony in this matter; likewise, expert 
testimony reflected in prior final orders has no place in an evaluation 
of the evidence in this matter.'' R.D. at 15-16 n.51. Insofar as the 
Agency's legal conclusions in prior final orders depend on expert 
testimony that is inconsistent with Professor Doering's testimony in 
this case, I agree with the CALJ that the legal conclusions in those 
cases are not called into question.
---------------------------------------------------------------------------

    \64\ Trinity II's argument implies that allowing the CALJ to 
find the same expert testimony reliable in one case (Holiday CVS), 
yet unreliable in this case, calls into question whether such 
findings are arbitrary and capricious. Although I agree with Trinity 
II and the Government that some of Professor Doering's testimony in 
Holiday CVS is consistent with his testimony in this case, I do not 
consider whether the CALJ's inconsistent reliability findings are 
arbitrary and capricious because I find, consistent with the CALJ's 
finding in Holiday CVS, that Professor Doering's testimony in this 
case is reliable.
---------------------------------------------------------------------------

    However, I disagree with the CALJ's claim that expert testimony 
accepted in prior final orders has no place in evaluating the weight to 
be given to expert testimony in this matter. Where Professor Doering's 
testimony in this case is consistent with expert testimony previously 
found reliable by the Agency, then I do find that prior consistent 
testimony relevant to an evaluation of the reliability of Professor 
Doering's testimony in this case. Here, for example, the Government 
contends that his ``testimony about the drug

[[Page 7328]]

utilization review obligations of a pharmacist'' regarding early fills 
``was consistent with the expert testimony that has been credited by 
[the] Agency in previous final decisions.'' ALJ Ex. 40a, at 73 (citing 
Grider #1 & Grider #2 and East Main Street Pharmacy), 86 (Professor 
Doering's testimony regarding the early fills in this case ``was 
consistent with the testimony of other experts in Agency precedent'') 
(citing Grider #1 & Grider #2 and The Medicine Dropper), 104 (Professor 
Doering's testimony regarding therapeutic duplication ``was again 
consistent with the testimony of another pharmacist expert that was 
credited by the Agency in a previous decision'') (citing Grider #1 & 
Grider #2 and Medicine Shoppe Jonesborough). Given Trinity II's further 
claim that Professor Doering's testimony is consistent with his own 
accepted testimony in Holiday CVS ``and its progeny,'' the fact that 
Professor Doering's testimony in this case is consistent with accepted 
expert testimony in the Agency's prior decisions is not in dispute. I 
find that this undisputed fact bolsters the reliability of Professor 
Doering's expert testimony--further undermining the CALJ's 
determination that in this case his testimony is not reliable.
    Accordingly, for all the foregoing reasons, I find that Professor 
Doering's expert testimony in this case was reliable under the APA.
The Public Interest Factors
    Under the Controlled Substances Act (``CSA''), ``[a] registration 
pursuant to section 823 of this title to manufacture, distribute, or 
dispense a controlled substance . . . may be suspended or revoked by 
the Attorney General upon a finding that the registrant . . . has 
committed such acts as would render [its] registration under section 
823 of this title inconsistent with the public interest as determined 
under such section.'' 21 U.S.C. 824(a)(4). In the case of a retail 
pharmacy, which is deemed to be a practitioner, see id. Sec.  802(21), 
Congress directed the Attorney General to consider the following 
factors in making the public interest determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id. Sec.  823(f).
    ``[T]hese factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem[ ] appropriate in determining whether'' to 
suspend or revoke an existing registration. Id.; see also MacKay v. 
DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 
222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). 
Moreover, while I am required to consider each of the factors, I ``need 
not make explicit findings as to each one.'' MacKay, 664 F.3d at 816 
(quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 
482.\65\
---------------------------------------------------------------------------

    \65\ In short, this is not a contest in which score is kept; the 
Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
or applicant's misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 
(2009). Accordingly, findings under a single factor can support the 
revocation of a registration or denial of an application. See 
MacKay, 664 F.3d at 821.
---------------------------------------------------------------------------

    Under the Agency's regulation, ``[a]t any hearing for the 
revocation or suspension of a registration, the Administration shall 
have the burden of proving that the requirements for such revocation or 
suspension pursuant to . . . 21 U.S.C. [Sec.  ]824(a) . . . are 
satisfied.'' 21 CFR 1301.44(e). In this matter, while I have considered 
all of the factors, the Government's evidence in support of its prima 
facie case is confined to factors two and four.\66\ I find that the 
record taken as a whole provides substantial evidence that Trinity II's 
pharmacists violated their corresponding responsibility pursuant to 21 
CFR 1306.04(a) when they dispensed many of the prescriptions at issue. 
I also find that the Government has established by substantial evidence 
that Trinity II's pharmacists filled prescriptions outside the usual 
course of their professional practice in violation of 21 CFR 1306.06.
---------------------------------------------------------------------------

    \66\ As to factor one, there is no evidence that the Florida 
Department of Health has either made a recommendation to the Agency 
with respect to Trinity II, or taken any disciplinary action against 
it. See 21 U.S.C. 823(f)(1). However, even if true, this finding is 
not dispositive of the public interest inquiry. See Mortimer Levin, 
57 FR 8680, 8681 (1992) (``[T]he Controlled Substances Act requires 
that the Administrator . . . make an independent determination [from 
that made by state officials] as to whether the granting of 
controlled substance privileges would be in the public interest.''). 
Accordingly, this factor is not dispositive either for, or against, 
the revocation of Trinity II's registration. Paul Weir Battershell, 
76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 6580, 6590 
(2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 (DC Cir. 
2008)).
    As to factor three, there is no evidence that Respondent, its 
owner, its manager, or any of its pharmacists, has been convicted of 
an offense under either federal or Florida law ``relating to the 
manufacture, distribution or dispensing of controlled substances.'' 
21 U.S.C. 823(f)(3). However, ``the absence of such a conviction is 
of considerably less consequence in the public interest inquiry'' 
and is therefore not dispositive. Dewey C. MacKay, 75 FR 49956, 
49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d 808 
(10th Cir. 2011).
    The Government did allege, in the alternative in the Show Cause 
Order's eighth charge, misconduct with respect to factor five 
regarding Trinity II's filling and dispensing of a controlled 
substance in an amount that was at least five times the amount 
prescribed. Because I consider this evidence in evaluating factors 
two and four, I deem it unnecessary to separately address this 
misconduct under factor five.
---------------------------------------------------------------------------

    Accordingly, I conclude that the Government has established that 
Trinity II committed numerous acts which render its continued 
``registration inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). Because I further agree with the ALJ's finding that Trinity 
II has not accepted responsibility for its misconduct, I also agree 
with the ALJ that it has not rebutted the Government's prima facie 
showing. Because I find that Trinity II's misconduct is egregious, I 
will order that Trinity II's registration be revoked and that any 
pending application be denied.
Factors Two and Four--The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

The Allegations Pursuant to 21 CFR 1306.04(a)

    ``Except as authorized by'' the CSA, it is ``unlawful for any 
person [to] knowingly or intentionally . . . manufacture, distribute, 
or dispense, or possess with intent to manufacture, distribute, or 
dispense, a controlled substance.'' 21 U.S.C. 841(a)(1). Under the Act, 
a pharmacy's registration authorizes it ``to dispense,'' id. Sec.  
823(f), which ``means to deliver a controlled substance to an ultimate 
user . . . by, or pursuant to the lawful order of, a practitioner, 
including . . . the packaging, labeling, or compounding necessary to 
prepare the substance for such delivery.'' Id. Sec.  802(10). ``The 
terms `deliver' or `delivery' mean the actual, constructive, or 
attempted transfer of a controlled substance.'' Id. Sec.  802(8). Thus, 
a pharmacy dispenses a controlled substance when it attempts to 
transfer a controlled substance to an ultimate user pursuant to a 
lawful

[[Page 7329]]

prescription by packaging or labeling a controlled substance for such 
delivery.
    The CSA's implementing regulations set forth the standard for a 
lawful controlled substance prescription. 21 CFR 1306.04(a). Under the 
regulation, ``[a] prescription for a controlled substance to be 
effective must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice.'' Id. Thus, `` `a practitioner is unauthorized to dispense a 
controlled substance if the prescription either lacks a legitimate 
purpose or is outside the usual course of professional practice.' '' 
United States v. Bennett, 874 F.3d 236, 245 (5th Cir. 2017) (quoting 
United States v. Armstrong, 550 F.3d 382, 397 (5th Cir. 2008), 
overruled on other grounds by United States v. Balleza, 613 F.3d 432, 
433 n.1 (5th Cir. 2010)). Continuing, the regulation provides that:

[t]he responsibility for the proper prescribing and dispensing of 
controlled substances is upon the prescribing practitioner, but a 
corresponding responsibility rests with the pharmacist who fills the 
prescription. An order purporting to be a prescription issued not in 
the usual course of professional treatment . . . is not a 
prescription within the meaning and intent of section 309 of the Act 
(21 U.S.C. 829) and the person knowingly filling such a purported 
prescription . . . shall be subject to the penalties provided for 
violations of the provisions of law relating to controlled 
substances.\67\
---------------------------------------------------------------------------

    \67\ As the Supreme Court has explained, ``the prescription 
requirement . . . ensures patients use controlled substances under 
the supervision of a doctor so as to prevent addiction and 
recreational abuse. As a corollary, the provision also bars doctors 
from peddling to patients who crave the drugs for those prohibited 
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United 
States v. Moore, 423 U.S. 122, 135, 143 (1975)).

Id. (emphasis added). Thus, 1306.04(a) distinguishes between 
``prescribing and dispensing'' and ``filling'' controlled substances, 
and who has responsibility for each function. Under this regulation, 
prescribing physicians are responsible for the ``proper prescribing and 
dispensing of controlled substances,'' and pharmacists bear a 
corresponding responsibility for ``filling'' only lawful prescriptions 
issued for a legitimate medical purpose.
    As the Agency has made clear, to prove a violation of a 
pharmacist's corresponding responsibility, the Government must show 
that the pharmacist acted with the requisite degree of scienter, i.e., 
that the pharmacist ``knowingly'' filled a prescription that was not 
issued for a legitimate purpose. See JM Pharmacy Group, Inc., d/b/a 
Farmacia Nueva and Best Pharma Corp., 80 FR 28667, 28669 (2015). Thus, 
the Government can prove a violation by showing either that the 
pharmacist filled a prescription (1) notwithstanding his/her actual 
knowledge that the prescription lacked a legitimate medical purpose, or 
(2) being willfully blind to (or deliberately ignorant of) the fact 
that the prescription lacked a legitimate medical purpose. See id. at 
28671-72. As to establishing that a pharmacist acted with ``willful 
blindness, proof is required that: `(1) the defendant must subjectively 
believe that there is a high probability that a fact exists and (2) the 
defendant must take deliberate actions to avoid learning of that fact.' 
'' Id. at 28672 (quoting Global-Tech Appliances, Inc., v. SEB S.A., 563 
U.S. 754, 769 (2011)).\68\
---------------------------------------------------------------------------

    \68\ Courts have long held that when prescriptions are clearly 
not issued for legitimate medical purposes, a pharmacist may not 
intentionally close his eyes and thereby deliberately avoid actual 
knowledge of the real purpose of the prescription, thereby filling 
them with impunity. See United States v. Kershman, 555 F.2d 198 (8th 
Cir. 1977). See also United States v. Lawson, 682 F.2d 480 (4th Cir. 
1982) (``The key element of knowledge may be shown by proof that the 
defendant deliberately closed his eyes to the true nature of the 
prescription'').
---------------------------------------------------------------------------

    Here, the Government makes no claim that any of Trinity II's 
pharmacists dispensed the prescriptions having actual knowledge that 
the prescriptions lacked a legitimate medical purpose. Instead, relying 
primarily on Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, 
77 FR 62316, 62341 (2012), the Government argues that a pharmacist 
violates the corresponding responsibility rule when he/she fills a 
controlled substance prescription (1) in the face of ``red flags'' or 
circumstances that do or should raise a reasonable suspicion as to the 
validity of a prescription and (2) without taking steps to resolve the 
red flag and ensure that the prescription is valid. ALJ Ex. 40a, at 66-
68. In this case, the Government argues that Trinity II's pharmacists 
violated 21 CFR 1306.04(a) by filling prescriptions for drugs such as 
oxycodone and hydromorphone, even though Trinity II's pharmacists knew 
that these prescriptions presented various ``red flags'' of diversion 
which were never resolved. Id. at 68.
    Notably, Florida law requires pharmacists to identify and resolve 
certain red flags for every prescription presented to them during a 
prospective drug use review. Florida Administrative Code Rule 64B-16-
27.810, entitled ``Prospective Drug Use Review,'' requires pharmacists 
to ``review the patient record and each new and refill prescription 
presented for dispensing in order to promote therapeutic 
appropriateness.'' ALJ Ex. 38 (Fla Admin Code r. 64B16-27.810(1)). This 
rule further requires that a pharmacist identify such issues as: 
``[o]ver-utilization,'' ``[t]herapeutic duplication,'' ``[d]rug-drug 
interactions,'' ``[i]ncorrect drug dosage or duration of drug 
treatment,'' and ``[c]linical abuse/misuse.'' Id.
    Importantly, ``[u]pon recognizing any of the above, the pharmacist 
shall take appropriate steps to avoid or resolve the potential problems 
which shall, if necessary, include consultation with the prescriber.'' 
Id. at 64B16-27.810(2). Thus, Trinity II's pharmacists violate Florida 
law if they fail to identify and resolve the red flags that are part of 
the prospective drug use review set forth in Rule 64B16-27.810. And if 
they knowingly fill prescriptions without resolving these red flags 
during this review, then they violate their corresponding 
responsibility under 21 CFR 1306.04(a). See, e.g., Grider Drug #1 & 
Grider Drug #2, 77 FR at 44097-98, 44100 (pharmacies violated their 
corresponding responsibility because they ``did not do prospective DUR 
[drug utilization review] with respect to any of the six patients even 
though this is required by the Kentucky Board of Pharmacy's rules''); 
East Main Street Pharmacy, 75 FR at 66157 & n.31 (pharmacists required 
to recognize and consider red flags as part of the prospective drug 
utilization review ``before they dispense a prescription'').
    Moreover, at all times relevant to this case, Florida law also 
required pharmacists to document resolution of a red flag. Rule 64B16-
27.800 \69\ required that ``[a] patient record system . . . be 
maintained by all pharmacies for patients to whom new or refill 
prescriptions are dispensed'' and that the ``system shall provide for 
the immediate retrieval of information necessary for the dispensing 
pharmacist to identify previously dispensed drugs at the time a new or 
refill prescription is presented for dispensing.'' Fla. Admin. Code r. 
64B-16-27.800. This rule also required that the pharmacy maintain ``[a] 
list of all new and refill prescriptions obtained by the patient at the 
pharmacy . . . during the two years immediately preceding the most 
recent entry'' and include the ``prescription number, name and strength 
of the drug, the quantity and date received, and the name of the 
prescriber.'' Id. at 64B-16-27.800(1)(e).
---------------------------------------------------------------------------

    \69\ Because the prescriptions at issue in this case are dated 
from February 2012-February 2014, I apply the version of Rule 64B16-
27.800 that applied prior to its amendment on March 18, 2015.
---------------------------------------------------------------------------

    Most significantly, the rule required that the record include the

[[Page 7330]]

``[p]harmacist['s] comments relevant to the individual's drug therapy, 
including any other information peculiar to the specific patient or 
drug.'' Id. at 64B-16-27.800(1)(f). And the rule also required that the 
pharmacist make ``a reasonable effort . . . to obtain from the patient 
. . . and record any known allergies, drug reactions, idiosyncrasies, 
and chronic conditions or disease states of the patient and the 
identity of any other drugs . . . being used by the patient which may 
relate to prospective drug review,'' id. at 64B-16-27.800(2), which is 
the ``prospective drug use review'' for red flags required by 64B-16-
27.810. Finally, the rule required that ``[t]he pharmacist . . . record 
any related information indicated by a licensed health care 
practitioner.'' Id. at 64B-16-27.800(2). All of these ``patient 
record[s]'' must be ``maintained for a period of not less than two 
years from the date of the last entry in the profile record.'' Id. at 
64B-16-27.800(4).
    Thus, Florida's laws specifically require a pharmacist to document 
in the patient record his/her comments relevant to the patient's drug 
therapy and ``other information peculiar to the patient'' or drug, as 
well as ``any related information'' provided by the patient's physician 
in the patient's ``profile record.'' Although such patient records 
provide relevant evidence in assessing whether a pharmacist resolved 
the suspicion created by the prescriptions at issue here, the 
Government only obtained and introduced patient profiles related to the 
23 Trinity II customers identified in its December 4, 2014 subpoena. GX 
98.\70\ As noted supra, the Government established by a preponderance 
of the evidence that Trinity II's pharmacists failed to resolve red 
flags regarding these patients because the prescriptions, dispensing 
logs, and patient profiles contained no documentation that Trinity II 
resolved the red flags of diversion presented by these customers' 
prescriptions. As a result, I further find that the Government 
established by a preponderance of the evidence that Trinity II's 
pharmacists filled at least some of the prescriptions knowing that they 
lacked a legitimate medical purpose.
---------------------------------------------------------------------------

    \70\ In Superior Pharmacy I and II, I found the Government's 
evidence, which was limited to the prescriptions (which contained no 
documentation that the red flags were resolved) and its Expert's 
testimony, insufficient to establish that the pharmacists violated 
their corresponding responsibility. 81 FR 31310 (2016).
---------------------------------------------------------------------------

    For example, the evidence shows that Trinity II knowingly filled 
controlled substances prescriptions well before the customer should 
have exhausted the supply obtained from a previous prescription filled 
by Trinity II. For one customer, J.T., Trinity II filled prescriptions 
for oxycodone 30 mg 14-16 days early on nine occasions in each of nine 
consecutive months--resulting in a cumulative effect of Trinity II 
filling and delivering \71\ 135 extra days of oxycodone 30 mg (the 
equivalent of 1,080 extra tablets) for J.T. from March 2012-November 
2012. While it is conceivable that a single early fill of a customer's 
prescription could be an unwitting mistake (albeit, at 16 days, a 
significant one) by one of Trinity II's pharmacists, it is not remotely 
credible that Trinity II could innocently repeat the same mistake nine 
times in nine consecutive months without knowing that the prescriptions 
lacked a legitimate medical purpose. Trinity II's pharmacists made no 
notes or comments on the front or back of these prescriptions, in the 
dispensing log, or in the patient profile explaining why J.T. should 
receive 135 extra days of oxycodone 30 mg. This lack of any explanation 
further highlights Trinity II's willingness to ignore the fact that 
J.T.'s early prescriptions lacked a legitimate medical purpose. This 
evidence of diversion of 135 extra days of a schedule II drug like 
oxycodone is so egregious that I find that it is more than sufficient 
to establish by a preponderance of the evidence that Trinity II's 
pharmacists were willfully blind \72\ to the fact that J.T.'s 
prescriptions lacked a legitimate medical purpose when its pharmacists 
filled them 14-16 days early in each of nine consecutive months. On 
this basis alone, I find that Trinity II violated its corresponding 
responsibility under 21 CFR 1306.04(a). Indeed, the Agency has 
previously found violations of the corresponding responsibility when 
pharmacists knowingly filled prescriptions less than 15 days early.\73\
---------------------------------------------------------------------------

    \71\ Given that J.T. came back on a monthly basis, it is a 
reasonable inference that the drugs were actually delivered to him.
    \72\ Moreover, this evidence would likely be sufficient to show 
that Trinity II had actual knowledge that these prescriptions lacked 
a legitimate medical purpose. However, the Government did not allege 
that Trinity II had such actual knowledge, making such a finding 
unnecessary.
    \73\ E.g., Grider Drug #1 and Grider Drug #2, 77 FR at 44098 
(finding a violation of the corresponding responsibility where the 
refills for one patient were ``more than five days early, and some 
as much as nine to twelve days early''); East Main Street Pharmacy, 
75 FR 66149, 66159 (2010) (accepting expert opinion that a refill of 
controlled substance ``two weeks early'' is a ``blatant example[ ] 
of abuse and diversion''); cf. Jeri Hassman, 75 FR 8194, 8201, 8229, 
8231 (2010) (finding prescriptions were not for a legitimate medical 
purpose where approximately half of the controlled substance 
``prescriptions were refilled five days early, with some being 
refilled as early as eight or nine days before the previous 
prescription would have run out'').
---------------------------------------------------------------------------

    Trinity II's pattern of early fills and refills was not limited to 
one customer. The evidence establishes that Trinity II filled 
prescriptions for customer M.A. for hydromorphone 8 mg six to seven 
days early on eight occasions in eight consecutive months--resulting in 
the cumulative effect of Trinity II filling and providing 50 extra days 
of hydromorphone 8 mg for M.A. from May 2013-December 2013. Trinity II 
also filled a prescription for customer J.G. for lorazepam 2 mg nine 
days early on May 28, 2013. In addition, Trinity II filled and refilled 
J.G.'s prescriptions for Xanax 2 mg early on six occasions between 
October 10, 2012 and June 12, 2013--five days early, six days early, 
eight days early, 10 days early (twice), and 17 days early. The 
evidence also establishes that Trinity II filled prescriptions for 
customer L.H. for hydromorphone 8 mg eight days early on June 28, 2012 
and nine days early on July 3, 2012.\74\ As with customer J.T., Trinity 
II's failure to document anywhere on the relevant prescriptions, 
dispensing logs, or patient profiles why M.A., J.G., or L.H. should 
receive early fills and refills of these controlled substances further 
underscores Trinity II's pharmacists' knowledge that they were filling 
illegitimate prescriptions and violating their corresponding 
responsibility under 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    \74\ These are only the most egregious examples of early filling 
of controlled substances by Trinity II in violation of its 
corresponding responsibility under Sec.  1306.04(a). As I described 
in my fact findings, Trinity II also filled a prescription for 
Dilaudid 8 mg nine days early for customer D.E. without explanation.
---------------------------------------------------------------------------

    In his Recommended Decision, the CALJ declined to find that Trinity 
II violated its corresponding responsibility under Sec.  1306.04(a) 
based on these early fills because of his belief that the determination 
of when a fill occurred must be based on ``the date when the customer 
picked up their medications,'' not when Trinity II filled the 
prescriptions. R.D. at 25. ``An early refill only logically bears upon 
this consideration [of over-utilization or under-utilization] at the 
moment the medication is being dispensed to the patient, not when a 
[fill] sticker is prepared by the pharmacy.'' Id. The CALJ offered the 
following explanation:

    While there may be some logical appeal to the principle that 
some or most of the steps required in a valid prospective drug use 
review should (and generally will) be completed prior to the 
preparation of the pharmacy fill sticker, no shred of that rationale 
could logically be applied to justify deeming the fill sticker 
preparation date as

[[Page 7331]]

equivalent to the date that a medication was dispensed (delivered/
transferred) to a patient for early refill purposes.
Id. The CALJ cites to no authority (and I am aware of none) for the 
proposition that the date when the customer actually receives the 
controlled substance should be used to determine whether a pharmacy's 
early fill of a prescription violates its corresponding responsibility 
under 21 CFR 1306.04(a).\75\
---------------------------------------------------------------------------

    \75\ Likewise, Trinity II contends that the date ``when the 
prescription was actually dispensed to the patient . . . and not the 
fill date, is the operative evidence of whether there was an 
improper dispensing event.'' Resp. Except. at 4; ALJ Ex. 41 at 16-17 
(``Doering was basing his often incorrect counting on the date the 
prescription was filled, without having any knowledge as to when the 
customer actually picked up the prescription''). Trinity II claims 
that its ``electronic records included patient signature logs for 
when the prescription was actually dispensed to the patient,'' Resp. 
Except. at 4, and as a result of this claim, the CALJ averred that 
the Government's expert ``could not determine the date the patients 
picked up their medications because he had never been provided with 
the pharmacy's disbursement log.'' R.D. at 25. In fact, neither the 
CALJ nor Trinity II cite to any authority (and I am aware of none) 
supporting their position that the date when the customer actually 
receives the controlled substance should be used to measure whether 
a pharmacy lawfully filled a prescription early under 21 CFR 
1306.04(a). To the extent that the CALJ and Trinity II rely on the 
definition of dispense, I discuss infra why such reliance is 
misplaced.

    Most importantly, the notion that the fill date is equivalent to 
the pick-up date is belied by Sec.  1306.04(a)'s plain language, which 
---------------------------------------------------------------------------
states in pertinent part:

    A prescription for a controlled substance to be effective must 
be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional 
practice. The responsibility for the proper prescribing and 
dispensing of controlled substances is upon the prescribing 
practitioner, but a corresponding responsibility rests with the 
pharmacist who fills the prescription. An order purporting to be a 
prescription issued not in the usual course of professional 
treatment . . . is not a prescription within the meaning and intent 
of section 309 of the Act (21 U.S.C. 829) and the person knowingly 
filling such a purported prescription . . . shall be subject to the 
penalties provided for violations of the provisions of law relating 
to controlled substances.

Id. (emphasis added). Section 1306.04(a) expressly requires pharmacists 
to identify and resolve suspicions that a prescription is illegitimate 
(like a prescription presented too early) before ``knowingly filling 
such a purported prescription.'' It does not allow a pharmacist to 
delay completing a prospective drug use review to confirm a suspicious 
prescription's legitimacy until ``a medication was dispensed 
(delivered/transferred) to a patient''--an event that necessarily 
occurs after the pharmacist has ``filled'' the prescription and which 
may even occur without the pharmacist's involvement at all. See R.D. at 
25.\76\ Such a rule would lead to the nonsensical result of allowing 
pharmacists to knowingly fill controlled substance prescriptions 
lacking a legitimate purpose so long as the pharmacist had not yet 
actually delivered them to the customer--directly contradicting Sec.  
1306.04(a)'s express prohibition.
---------------------------------------------------------------------------

    \76\ The CALJ surmised that, unless the pharmacist's 
corresponding responsibility is delayed until ``the moment the 
medication is being dispensed to the patient,'' then ``any ethical 
Florida pharmacist who works ahead and prepares medications in 
advance of their eligibility to be picked up by the patient due to 
staffing or some other benign business-related issue would stand in 
unavoidable conflict with the standard of pharmacy practice in 
Florida merely by virtue of the date on the fill sticker.'' R.D. at 
25. Aside from the fact that the record does not show that Trinity 
II routinely filled prescriptions ``in advance of their eligibility 
to be picked up,'' no Agency precedent supports the CALJ's 
hypothetical as some kind of exception to a pharmacist's 
corresponding responsibility. In fact, Sec.  1306.04(a) precludes 
the CALJ's hypothetical by imposing a corresponding responsibility 
on the pharmacist at the time of ``filling,'' not at some point 
after filling the prescription. Thus, to fulfill their corresponding 
responsibility under Sec.  1306.04(a), pharmacists must identify and 
resolve any red flags of diversion presented by controlled substance 
prescriptions (e.g., by completing the prospective drug use review 
that Florida law required Trinity II to do) before filling them in 
order to avoid ``knowingly filling'' illegitimate prescriptions.
---------------------------------------------------------------------------

    And to the extent the CALJ's view is based on the notion that 
``fill'' means ``dispense,'' or that the two terms are otherwise 
interchangeable, Sec.  1306.04(a)'s plain language precludes that 
notion as well. Specifically, Sec.  1306.04(a) distinguishes a 
prescribing practitioner's ``responsibility for the proper prescribing 
and dispensing of controlled substances'' only for a legitimate medical 
purpose from the pharmacist's corresponding responsibility not to 
``knowingly fill[ ]'' prescriptions that lack a legitimate medical 
purpose. Filling constitutes part of the process of dispensing, but the 
CALJ cites to no decision of the Agency (and I am aware of none) 
holding that filling encompasses every part of the dispensing process, 
including the actual delivery to the ultimate user. If ``dispensing'' 
and ``filling'' shared the same meaning, then the Agency would not have 
used two different terms in the same regulation to describe prescribing 
practitioners' and pharmacists' respective responsibilities. Instead, 
the Agency would have simply used the term ``dispense'' to apply to 
both practitioners and pharmacists throughout the regulation. Thus, I 
reject the notion that under Sec.  1306.04(a), the term ``fill'' is 
coextensive with the term ``dispense,'' which includes the delivery of 
a controlled substance.
    Just as the operative date for determining whether a prescribing 
practitioner has met his/her responsibility under Sec.  1306.04(a) is 
when the physician ``prescribe[s] and dispens[es]'' a controlled 
substance, the operative date for determining whether a pharmacist has 
met his/her corresponding responsibility is when the pharmacist ``fills 
the prescription.'' \77\ And as noted supra, the record establishes by 
a preponderance of the evidence that the date on Trinity II's fill 
stickers represent the date when Trinity II's pharmacists filled the 
prescriptions at issue in this case. Accordingly, Sec.  1306.04(a) 
required Trinity II to identify and to resolve any suspicions that a 
particular prescription lacked a legitimate medical purpose before 
knowingly filling the prescription.
---------------------------------------------------------------------------

    \77\ Furthermore, even if Sec.  1306.04(a) did impose on 
pharmacists a corresponding responsibility not to ``knowingly 
dispense'' an illegitimate prescription (rather than prohibiting 
them from ``knowingly filling such a purported prescription''), the 
calculation of an ``early fill'' would be the same. Under the CSA, 
`` `dispense' means to deliver a controlled substance to an ultimate 
user . . . by, or pursuant to the lawful order of, a practitioner, 
including . . . the packaging, labeling, or compounding necessary to 
prepare the substance for such delivery.'' 21 U.S.C. 802(10). ``The 
terms `deliver' or `delivery' mean the actual, constructive, or 
attempted transfer of a controlled substance.'' Id. Sec.  802(8). 
Thus, the situations in which a pharmacy ``dispenses'' a controlled 
substance includes when the pharmacy attempts to transfer a 
controlled substance to an ultimate user pursuant to a lawful 
prescription ``by packaging or labeling a controlled substance for 
such delivery''--i.e., before a customer actually receives the 
prescribed controlled substance. As the Government points out in its 
Exceptions, even under Florida's definition, ``dispensing'' occurs 
before the customer receives the prescription. Gov. Except. at 46 
(noting that Florida's `dispense' definition in Ch. 465.003(6) 
unequivocally states that ``the actual sales transaction and 
delivery of such drug shall not be considered dispensing'') (quoting 
Fla. Stat. Sec.  465.003(6)). In this case, when Trinity II filled a 
bottle with a prescribed controlled substance and then affixed a 
fill label or sticker to the bottle or ``packaging'' containing the 
controlled substance, Trinity II ``dispensed'' the prescription 
under the CSA (and arguably Florida law) by ``labeling . . . the 
substance for'' ``delivery to an ultimate user.'' The record 
reflects that the date on the fill sticker represents the date when 
Trinity II packaged or labeled a prescribed controlled substance. 
And as the CALJ concedes, ``the date on the fill sticker'' is also 
what the Government used to calculate the date when Trinity II 
``filled'' the prescriptions at issue in the case. See R.D. at 25. 
Accordingly, even under the theory that ``fill'' in Sec.  1306.04(a) 
really means ``dispense,'' the date on the fill sticker in this case 
reflects both the ``fill'' date and the ``dispense'' date.
---------------------------------------------------------------------------

    As noted supra, the evidence of Trinity II's improper early fills 
alone is sufficient to prove that Trinity II knowingly filled 
illegitimate prescriptions in violation of its corresponding 
responsibility under Sec.  1306.04(a). However, there are other

[[Page 7332]]

examples of suspicious prescriptions nonetheless filled by Trinity II 
that further prove that Trinity II knowingly filled prescriptions 
lacking a legitimate medical purpose. For instance, the evidence 
established that on December 2, 2013, Trinity II knowingly filled two 
therapeutically duplicative prescriptions for customer R.H.--one for 
120 tablets of hydromorphone 8 mg and a second for 120 tablets of 
oxycodone 30 mg. Each immediate-release opiate prescription had the 
same dosage instruction to take one tablet every six hours. The Agency 
has previously found that therapeutically duplicative prescriptions 
raise a strong suspicion of diversion, and a pharmacist who fails to 
resolve this suspicion before knowingly filling the prescription 
violates his/her corresponding responsibility under Sec.  1306.04(a). 
See The Medicine Shoppe, 79 FR 59504, 59507 & n. 10 (2014) (finding 
that prescriptions for ``duplicative narcotics'' is evidence of 
diversion, and knowingly filling such prescriptions without resolving 
this strong suspicion violates Sec.  1306.04(a)). Here, Trinity II's 
pharmacists offered no notes or comments on the front or back of these 
prescriptions, the dispensing log, or in the patient profile explaining 
why R.H. should have received these two therapeutically duplicative 
prescriptions. Thus, I find that Trinity II's pharmacist's decision to 
fill R.H.'s therapeutically duplicative prescriptions without 
explanation, combined with the early fill evidence already described, 
also shows that Trinity II knowingly filled prescriptions that lacked a 
legitimate medical purpose.
    In addition, the evidence shows that Trinity II knowingly and 
routinely filled controlled substance prescriptions presented by 
customers who had traveled great distances to fill them, even though 
the Agency has previously held that prescriptions by such customers 
should cause pharmacists to suspect that the prescriptions are not 
legitimate.\78\ For example, on June 5, 2013, customer S.S. traveled 
across the entire state of Florida--and approximately 397 miles 
roundtrip--to obtain from his physician in Tampa and to fill at Trinity 
II in Clearwater his prescription for 150 tablets of hydromorphone 8 
mg. On May 10, 2012, customer C.V. traveled from his home in Port 
Charlotte, Florida--an approximately 224 miles roundtrip--to obtain 
from his physician in Tampa and to fill at Trinity II his prescription 
for 120 tablets of hydromorphone 8 mg. On June 13, 2013 and on July 3, 
2013, customer D.E. traveled from his home in Brooksville, Florida--an 
approximately 119 miles roundtrip--to obtain from his physician in 
Tampa and to fill at Trinity II identical prescriptions for 
hydromorphone 8 mg. As already noted, Trinity II also filled the July 
3, 2013 prescription nine days early--adding to the suspiciousness of 
this particular prescription's legitimacy. Nevertheless, even though 
Trinity II knew the addresses of S.S.,\79\ C.V., D.E., and their 
respective physicians, the evidence shows that Trinity II failed to 
document why it nonetheless filled the schedule II controlled substance 
prescriptions for these customers.
---------------------------------------------------------------------------

    \78\ E.g., East Main Street Pharmacy, 75 FR 66,149, 66,153 & n. 
16, 66,163-66,164 (2010) (finding that traveling nearly 100 miles to 
pharmacy ``provided further reason to know that the prescriptions 
were not legitimate'' and that customers traveling 90 miles from 
their residence to the pharmacy constituted ``travelling great 
distances to fill their prescriptions'' and concluding ``the fact 
that the patients were driving so far to get their prescriptions 
filled `would be a major red flag for any pharmacist''').
    \79\ The fill sticker that Trinity II generated and attached to 
the back of the prescription, the dispensing log, and the patient 
profile all show S.S.'s address to be in Orange Park, Florida, which 
is a city located near Jacksonville, Florida. GX 44, at 1, 2, 9; Tr. 
1680. However, as noted supra, the front of the prescription lacked 
S.S.'s address. As a result, the Government alleged that Trinity 
II's filling of this prescription constitutes an independent 
violation of 21 CFR 1306.05, which requires, inter alia, all 
prescriptions for controlled substances to bear the full name and 
address of the patient and imposes a corresponding liability ``upon 
the pharmacist . . . who fills a prescription not prepared in the 
form prescribed by DEA regulations.'' Id. at Sec.  1306.05(a), (f). 
The CALJ also recommended that I find that Trinity II violated 21 
CFR 1306.05. See R.D. at 46. At the time these prescriptions were 
issued, the Agency had made a public pronouncement that, if missing, 
pharmacists could add a patient's address if state law allowed it. 
See Superior I and II, 81 FR at 31336 n.58. Here, the Government has 
produced no evidence that Florida law, the Board of Pharmacy's 
regulations, or the Board's policy prohibited Trinity II's 
pharmacists from adding the patient's address to the prescriptions.
---------------------------------------------------------------------------

    The travel of customer D.W. deserves special mention. He traveled 
all the way from Wellborn, Florida--an approximately 404 miles 
roundtrip--to obtain from his physician in Tampa and to fill at Trinity 
II controlled substance prescriptions for oxycodone 30 mg with ginger 
and carisoprodol 350 mg on three separate occasions in March, April, 
and May of 2012. Moreover, D.W. endured the added inconvenience of 
traveling on different dates to fill his second and third prescriptions 
of each of these controlled substances--filling two prescriptions for 
oxycodone with ginger on April 5, 2012 and on May 3, 2012, and two 
prescriptions of carisoprodol on April 19, 2012 and on May 11, 2012. 
The fact that D.W. was willing to travel these distances so frequently, 
and inefficiently, just to fill these controlled substances 
prescriptions at Trinity II should have highlighted for its pharmacists 
just how unlikely it was that these prescriptions were filled for a 
legitimate medical purpose. Nevertheless, even though Trinity II knew 
how far away D.W. lived, Trinity II failed to document why it still 
filled D.W.'s highly suspicious controlled substance prescriptions.
    Accordingly, Trinity II's pharmacists' knowledge of the great 
distances traveled by these customers, combined with their failure to 
document why their prescriptions should nonetheless be filled, shows 
that Trinity II's pharmacists knew that these prescriptions lacked a 
legitimate medical purpose.
    The evidence further shows that Trinity II routinely filled 
``cocktail prescriptions'' in which customers simultaneously presented 
multiple prescriptions that would provide the same customer an opioid, 
a benzodiazepine, and carisoprodol (a muscle relaxant). Trinity II 
routinely filled these ``cocktail prescriptions'' even though the 
Agency has identified this combination of drugs in several final 
decisions as being highly abused prior to the events at issue here. See 
Paul Volkman, 73 FR 30630, 30637 (2008); see also East Main Street 
Pharmacy, 75 FR at 66157-58. Nevertheless, on June 27, 2013 and July 
23, 2013, Trinity II filled for customer S.S. prescriptions for the 
same combination of controlled substances--an opioid (hydromorphone 8 
mg), a benzodiazepine (alprazolam 2 mg), and carisoprodol 350 mg--on 
each date. This is also the same customer who had traveled across the 
entire state of Florida to obtain these prescriptions--further 
highlighting the suspicious nature of his prescriptions. See supra. 
Trinity II's pharmacists provided no notes or comments explaining why 
they knowingly filled these ``cocktail'' prescriptions. Id. Thus, I 
find that Trinity II's pharmacists' knowledge that these prescriptions 
reflected a well-established suspicious ``cocktail'' of controlled 
substances for a customer who they also knew had traveled across the 
entire state of Florida established that Trinity II's pharmacists knew 
that these prescriptions lacked a legitimate purpose.
    Likewise, the record shows that on March 7, 2012, May 3, 2012, and 
May 31, 2012, Trinity II filled prescriptions for the same ``cocktail'' 
of controlled substances--an opioid (oxycodone 30 mg), a benzodiazepine 
(alprazolam 2 mg), and carisoprodol--issued by the same prescribing 
physician to customers J.Ha. and R.Ha. on each date. And yet,

[[Page 7333]]

Trinity II's pharmacists never explained why they filled these highly 
suspicious prescriptions. The suspiciousness of these ``cocktail 
prescriptions'' was further compounded by the fact that these 
prescriptions also reflected ``pattern prescribing'' and a lack of 
individualized drug therapy. Specifically, Trinity II knew that J.Ha. 
and R.Ha. shared a last name and home address and that their 
prescriptions were issued (1) by the same prescribing physician, (2) on 
the same day, and (3) for the same drugs.\80\ Trinity II's pharmacists 
provided no notes or comments explaining why they knowingly filled 
these prescriptions. See supra. Thus, I find that the fact that Trinity 
II's pharmacists' knew that these prescriptions reflected a well-
established suspicious ``cocktail'' of controlled substances for two 
customers who also shared the same last name, address, and prescribing 
physician, established that Trinity II's pharmacists knew that these 
prescriptions lacked a legitimate purpose.
---------------------------------------------------------------------------

    \80\ See East Main Street Pharmacy, 75 FR at 66,157 (noting red 
flags such as ``lack of indivdua[liza]tion of therapy, certain 
patterns from physicians of seeing the same types of controlled 
substances over, and over, and over, again''). This is not the only 
example of Trinity II filling prescriptions presenting this type of 
``pattern prescribing.'' On two occasions--November 20, 2013 and 
December 18, 2013--Trinity II filled prescriptions for customers 
M.W. and J.W. for the same controlled substance (oxycodone 30 mg 
with ginger), even though Trinity II knew that these customers 
shared the same last name, address and prescribing physician. 
Trinity II's pharmacists never explained why they nonetheless filled 
these prescriptions. As a result, I find that it is highly probable 
that Trinity II's pharmacists knew that these prescriptions also 
lacked a legitimate medical purpose.
---------------------------------------------------------------------------

    Accordingly, and in light of the very substantial weight of the 
evidence of diversion presented by the suspicious prescriptions in this 
case--early fills, therapeutic duplication, customers traveling great 
distances, ``cocktail prescriptions,'' and ``pattern prescribing''--I 
find that Trinity II's pharmacists violated their corresponding 
responsibility by knowingly filling prescriptions that lacked a 
legitimate medical purpose.

The Allegations Pursuant to 21 CFR 1306.06

    Under 21 CFR 1306.06, ``[a] prescription for a controlled substance 
may only be filled by a pharmacist, acting in the usual course of his 
professional practice.'' Pharmacists fill prescriptions for controlled 
substances in the usual course of their professional practice, for 
example, when pharmacists follow the prescribing physician's 
instructions for a prescription issued for a legitimate medical 
purpose. When pharmacists knowingly fail to follow such instructions in 
filling otherwise valid prescriptions, they are not ``acting in the 
usual course of [their] professional practice'' and therefore violate 
21 CFR 1306.06.
    Here, Trinity II filled prescriptions without following the 
prescribing physician's instructions with respect three of the Show 
Cause Order's charges. Specifically, in the third and fourth charges of 
the Show Cause Order, the Government charged Trinity II with twice 
filling prescriptions for customer D.G. for fentanyl patches on dates 
prior to the prescribing physician's explicit ``No Exceptions Do Not 
Fill Until'' instructions on each prescription. As noted supra, I have 
found that the Government proved these facts by a preponderance of the 
evidence.\81\ Although he did not rely on 21 CFR 1306.06,\82\ the CALJ 
recommended that I sustain the Government's third and fourth charges. I 
do sustain those charges, but only on the basis that Trinity II 
violated 21 CFR 1306.06 \83\ when it filled \84\ these prescriptions

[[Page 7334]]

before the prescribing physician's ``Do Not Fill'' instructions.
---------------------------------------------------------------------------

    \81\ In addition, I find that there is no evidence establishing 
that the ``Do Not Fill'' prescriptions underlying the Show Cause 
Order's third and fourth charges were invalid under 21 CFR 
1306.04(a) and 1306.11(a). For this reason, I deny the Government's 
allegation that Trinity II also (1) violated their corresponding 
responsibility under 21 CFR 1306.04(a) when they filled these two 
prescriptions and (2) filled a prescription without a valid 
prescription in violation of 21 CFR 1306.11(a) regarding these 
prescriptions. See ALJ Ex. 1b, at 14-15.
     It is also for this reason that I disagree with the CALJ's 
statement that, ``[b]ecause the scrip[t] was not valid until the 
date articulated by the practitioner, . . . the Respondent filled 
these two prescriptions without a lawful order from a 
practitioner.'' R.D. at 49. As the CALJ himself noted in 
recommending that I reject the Government's claim of a Sec.  
1306.11(a) violation regarding the Show Cause Order's fifth charge, 
``because there was a (seemingly) valid scrip[t] presented for each 
of these dispensing events,'' Trinity II's conduct should not be 
reviewed ``as if it were dispensed with no [valid] order from the 
practitioner.'' Id. at 49 n.116. I agree. In the Show Cause Order's 
third, fourth, and fifth charges, customers presented apparently 
valid prescriptions to Trinity II, but its pharmacists ignored 
(repeatedly) the same instructions when filling them. Thus, I agree 
with the CALJ's argument regarding the fifth charge, and I apply the 
same argument in rejecting his rationale regarding the third and 
fourth charges.
    \82\ The CALJ criticized the Government for not relying on 21 
CFR 1306.12 and 21 CFR 1306.14 as a basis for the third and fourth 
charges. R.D. at 47 n.111 (``It is difficult to imagine why the 
Government did not cite to these regulatory sections, which speak 
directly to the violations at issue in OSC ]] 9 and 10.''). However, 
the CALJ's own analysis supplies a good explanation for why the 
Government did not pursue charges on that basis. The CALJ conceded 
that ``those regulatory sections specifically pertain to the 
situation where a practitioner issues multiple prescriptions, 
presumably on the same date.'' Id. at 47. He further referenced 
DEA's ``notice of final rule implementing the regulation,'' in which 
``DEA noted that the rule `did not address whether a single 
prescription with ``Do not fill before [date]'' instructions is 
permissible' '' and that ``no `existing provision of the CSA or DEA 
regulations address[es] this type of prescribing.' '' Id. at 47-48 
(quoting ``Issuance of Multiple Prescriptions for Schedule II 
Controlled Substances,'' 72 FR 64,921-64,924 (2007)). Here, the ``Do 
Not Fill'' prescriptions underlying the Show Cause Order's third and 
fourth charges were not issued on the same date and hence are not 
``multiple prescriptions'' on the same date within the meaning of 21 
CFR 1306.12(b).
    \83\ Federal courts have suggested that the identical phrase--
``usual course of his professional practice''--found in 21 CFR 
1306.04(a) essentially includes a knowingly requirement in criminal 
cases. See, e.g., Bennett, 874 F.3d at 245 (finding that a 
prescribing physician violates Sec.  1306.04(a) when the 
practitioner ``knowingly distribut[es] prescriptions outside the 
usual course of professional practice'') (internal citations and 
quotations omitted). Assuming the ``knowingly'' scienter standard 
applies to the application of Sec.  1306.06 to this administrative 
proceeding, I find that the Government has met its burden to prove 
it. The Government's burden of proof in this proceeding is 
``preponderance of the evidence,'' not ``beyond a reasonable 
doubt.'' In that vein, while it is conceivable that a Trinity II 
pharmacist may mistakenly fail to follow ``Do Not Fill Until'' 
instructions in good faith once, it is less credible that Trinity 
II's pharmacists would fail to follow such instructions for the same 
customer two months in a row without doing so knowingly. The CALJ 
apparently agreed. R.D. at 48-49 (``Despite the clear indication of 
the practitioner's limitation on the scrip[t]s, Respondent's 
employees blatantly ignored the instruction and filled the 
prescriptions before the practitioner had authorized them to be 
filled.''). When this pattern is combined with the broader pattern 
of Trinity II's pharmacists knowingly filling prescriptions in 
violation of their corresponding responsibility, see supra, I have 
little trouble finding that the Government has established by a 
preponderance of the evidence that Trinity II's pharmacists 
knowingly failed to follow the ``Do Not Fill Until'' instructions in 
D.G.'s prescriptions and hence filled prescriptions outside the 
pharmacists' usual course of their professional practice under 21 
CFR 1306.06.
    In any event, even if the Government could not prove that this 
conduct violated Sec.  1306.06 or otherwise met Factors Two or Four 
under 21 U.S.C. 823(f), I find that a pharmacist blatantly and 
knowingly ignoring a physician's instructions on an otherwise valid 
prescription would constitute ``[s]uch other conduct which may 
threaten the public health and safety.'' 21 U.S.C. 823(f)(5). See 
R.D. at 48 (``To allow a pharmacy to fill a prescription at any time 
before a date specified by the issuing practitioner would completely 
undermine the practitioner's decision to issue the scrip[t] in that 
manner.'').
    \84\ In its Exceptions, Trinity II offered its conclusory 
argument that the date ``when the prescription was actually 
dispensed to the patient . . . and not the fill date, is the 
operative evidence of whether there was an improper dispensing 
event. Because the Government never requested'' ``the pharmacy's 
electronic records [which] included patient signature logs,'' 
``there was insufficient evidence to meet the Government's burden of 
proof for this allegation.'' Resp. Except. at 4. I reject this 
Exception for the same two reasons that I rejected the same argument 
supra in the context of Trinity II's violations of 21 CFR 
1306.04(a). Like Sec.  1306.04(a), 21 CFR 1306.06 expressly hinges 
on whether pharmacists ``filled'' controlled substance prescriptions 
in the usual course of their professional practice; it does not 
depend on ``when the prescription was actually dispensed to the 
patient'' as Trinity II claims. Thus, the ``operative evidence'' is 
the evidence of filling, and the CALJ properly reviewed the dates on 
the fill sticker, the front of the prescription, and the dispensing 
report to identify the fill date. Second, for the reasons I have 
already discussed supra, the dispensing date would ultimately have 
been the same as the fill date.
---------------------------------------------------------------------------

    In the Show Cause Order's fifth charge, the Government alleged, and 
as noted supra I have found, that Trinity II filled for customer J.T. 
seven consecutive prescriptions for a morphine sulfate solution that 
was at least five times, and sometimes 15 times, stronger than the 
dosages that the physician had prescribed. Although the Government 
charged that this conduct violated 21 CFR 1306.06 and 21 CFR 
1306.11(a), I find that the conduct did not violate 21 CFR 1306.11(a) 
because I find that there is no proof that the prescriptions underlying 
the Show Cause Order's fifth charge were invalid. See R.D. at 49 n.116 
(``there was a (seemingly) valid scrip[t] presented for each of these 
dispensing events''). For this reason, the CALJ recommended that I deny 
the Government's allegation that Trinity II filled prescriptions in the 
fifth charge without a valid prescription and in violation of 21 CFR 
1306.11(a) regarding these prescriptions. See id.
    Although he did not rely on 21 CFR 1306.06,\85\ the CALJ 
nonetheless recommended that I sustain the Government's fifth charge. I 
do sustain this charge, but only on the basis that Trinity II violated 
21 CFR 1306.06. As with D.G.'s prescriptions in the third and fourth 
charges, customer J.T. presented apparently valid prescriptions to 
Trinity II, but the Government proved the allegations in its fifth 
charge that Trinity II's pharmacists repeatedly ignored the 
prescriptions' instructions when filling them. While it is conceivable 
that a Trinity II pharmacist may have mistakenly failed to follow a 
prescription's dosage instructions in good faith once, it is not 
remotely credible that Trinity II's pharmacists would fail to follow 
such instructions for the same customer seven times in the span of six 
months without doing so knowingly. For this reason, I have little 
trouble finding that the Government has established by a preponderance 
of the evidence that Trinity II's pharmacists knowingly filled 
prescriptions with the incorrect dosage strength of a controlled 
substance seven times and hence filled prescriptions outside the 
pharmacists' usual course of their professional practice in violation 
of Sec.  1306.06.
---------------------------------------------------------------------------

    \85\ The CALJ recommended that I find that Trinity II's conduct 
in the Show Cause Order's fifth charge violated Trinity II's 
corresponding responsibility under 21 CFR 1306.04(a) because ``the 
regulation's plain language imposes a corresponding responsibility 
on the pharmacist `for the proper . . . dispensing' of the 
prescription. Dispensing a stronger concentration of a controlled 
substance than has been authorized by the practitioner is a 
violation of that corresponding responsibility.'' R.D. at 49.
    The CALJ's interpretation of Sec.  1306.04(a) is incorrect for 
at least two independent reasons. First, as noted supra, pharmacists 
violate their corresponding responsibility when they ``knowingly 
fill[ ]'' a prescription that lacks a legitimate purpose. The CALJ 
has already recommended that I find (and I have so found) that the 
underlying prescriptions at issue in the fifth charge were valid, 
R.D. at 49 n. 116 (``there was a (seemingly) valid scrip[t] 
presented for each of these dispensing events''), making impossible 
a finding that Trinity II's pharmacists knowingly filled 
illegitimate prescriptions in violation of Sec.  1306.04(a). Second, 
also as noted supra, the plain language of Sec.  1306.04(a) 
assigns`` [t]he responsibility for the proper prescribing and 
dispensing of controlled substances . . . upon the prescribing 
practitioner,'' not upon the pharmacists, whose corresponding 
responsibility expressly relates to filling, not dispensing. Indeed, 
it is likely for these reasons that the Government did not claim 
that Trinity II violated its corresponding responsibility in the 
Show Cause Order's fifth charge.
---------------------------------------------------------------------------

The Allegations Regarding Prescriptions Filled by Non-Pharmacists

    In the Show Cause Order's final two charges, the Government alleged 
that Trinity II violated federal and Florida law when it allowed 
pharmacist interns to fill controlled substances prescriptions. Section 
1306.06 provides that controlled substances prescriptions ``may only be 
filled by a pharmacist.'' Federal law states that a pharmacist ``means 
any pharmacist licensed by a State to dispense controlled substances, 
and shall include any other person (e.g., pharmacist intern) authorized 
by a State to dispense controlled substances under the supervision of a 
pharmacist licensed by such State.'' 21 CFR 1300.01(b).
    In his Recommended Decision, the CALJ found that Florida law 
authorized pharmacy interns to dispense controlled substances. 
Specifically, the CALJ found that Florida defined a ``pharmacist'' as a 
person ``licensed pursuant to chapter 465 to practice the profession of 
pharmacy'' in Florida, and that Chapter 465 in turn defines the 
``practice of the profession of pharmacy'' to include ``dispensing.'' 
R.D. at 44 (quoting Fla. Stat. Sec. Sec.  893.02(18), 465.003(13)). The 
CALJ also found that Florida law states that a ``person other than a 
licensed pharmacist or pharmacy intern may not engage in the practice 
of pharmacy.'' R.D. at 44 (quoting Fla. Stat. Sec.  465.014(1)). On 
this legal basis, the CALJ recommended that I find that ``both 
pharmacists and pharmacy interns are authorized under Florida law to 
`practice the profession of pharmacy,' which includes dispensing. 
Therefore, it is acceptable for pharmacy interns to dispense controlled 
substances under Florida law and under the DEA regulations.'' R.D. at 
44.
    In its Exceptions, the Government took issue with the CALJ's 
characterization of Florida law and whether it authorized pharmacist 
interns to dispense controlled substances under the supervision of a 
licensed Florida pharmacist. The Government contended that Sec.  
893.04(1) of Chapter 893 of Florida law states that controlled 
substance prescriptions may only be dispensed by ``a pharmacist, in 
good faith and in the course of professional practice''--making no 
reference to pharmacy interns. Gov. Except. at 78. The Government also 
argued that pharmacy interns are not ``licensed pursuant to Chapter 465 
to practice the profession of Pharmacy'' as required under Sec.  
893.02(18) but instead are ``registered with the'' state under Sec.  
465.03(12). Gov. Except. at 79. For these reasons, the Government asked 
me to reject the CALJ's recommendation and find that pharmacy interns 
are essentially never authorized to dispense controlled substances 
prescriptions in Florida. Id. at 80.
    I find that both the CALJ and the Government have misinterpreted 
Florida law. Although Florida law is not as clear as federal law in 
this regard, Florida law neither permits all pharmacy interns to 
dispense controlled substances (as the CALJ recommended), nor prohibits 
all pharmacy interns from doing so (as the Government claims). Rather, 
Florida law permits pharmacy interns to dispense controlled substances 
only when they are under the statutorily prescribed supervision of a 
licensed pharmacist. For example, Florida statutes makes it unlawful 
for an intern registered in Florida to ``fill, compound, or dispense 
prescriptions or to dispense medicinal drugs'' if the intern is ``not 
acting under the direct and immediate personal supervision of a 
licensed pharmacist.'' Fla Stat. Sec.  465.015(2)(b). Florida law also 
authorizes disciplinary actions against pharmacists ``permitting a 
registered intern who is not acting under the direct and immediate 
personal supervision of a licensed pharmacist, to fill, compound, or 
dispense any prescriptions in a pharmacy owned and operated by such 
pharmacists or in a pharmacy where such pharmacists are employed or on 
duty.'' Id. 465.016(1)(c) (emphasis added). In addition, Florida's 
Administrative Code states that ``[n]o intern shall perform any acts 
relating the filling, compounding, or dispensing of medicinal drugs 
unless it is done under the direct and immediate personal supervision 
of a person actively licensed to practice pharmacy

[[Page 7335]]

in this state.'' Fla. Admin. Code r. 64B16-26.400 (emphasis added). 
Thus, I find that it is lawful in Florida for a pharmacy intern, 
registered in Florida, to fill and to dispense prescriptions so long as 
it is under the statutorily prescribed supervision of a licensed 
Florida pharmacist.
    Here, even assuming arguendo as true the Government's allegations 
that Mina A. Ghobrial was a pharmacy intern who worked at Trinity II 
and filled controlled substances prescriptions during the alleged time 
period, I have already found that the Government failed to establish 
that Ghobrial was not supervised by a licensed Florida pharmacist when 
Ghobrial did so. See supra. Accordingly, I agree with the CALJ's 
recommendation that I find (and I do so find) that the Government has 
failed to carry its burden that Ghobrial was not properly supervised 
under Florida law, and I agree with the CALJ's recommendation that I 
reject (and I do so reject) the Show Cause Order's sixth and seventh 
charges.
Summary of Factors Two and Four
    As found above, Trinity II's pharmacists knowingly filled dozens of 
controlled substance prescriptions for more than a dozen patients even 
though those prescriptions lacked a legitimate medical purpose. 21 CFR 
1306.04(a). Moreover, Trinity II's pharmacists knowingly and repeatedly 
ignored the instructions set forth in legitimate prescriptions issued 
to two of its customers and thereby failed to fill them in the usual 
course of their professional practice. 21 CFR 1306.06. Thus, I conclude 
that Trinity II has engaged in egregious misconduct which supports the 
revocation of its registration. See Dewey C. MacKay, 75 FR 49956, 49997 
(2010); Krishna-Iyer, 74 FR at 463; Alan H. Olefsky, 57 FR 928, 928-29 
(1992). I therefore hold that the Government has clearly established 
its prima facie case that Trinity II's registration ``would be 
inconsistent with the public interest.'' 21 U.S.C. 823(f).
    In its Exceptions, Trinity II argued that, ``[e]ven assuming that 
the DEA met its burden of proof, '' the CALJ ``erred in failing to 
balance the relatively de minimis problems that the ALJ found were 
supported by the preponderance of the evidence against the number of 
prescriptions during the [two-year] audit period in which there was no 
problem.'' Resp. Except. at 5 (citing Iyer v. DEA, 249 Fed. Appx. 159, 
160 (11th Cir. 2007) (unpublished). Specifically, Trinity II claims 
that ``the sanction of revocation . . . is not supported'' because the 
CALJ found that ``approximately 0.07%'' of the prescriptions filled by 
Trinity II violated the law. Id. at 5-6.
    Trinity II's challenge to the CALJ's recommendation of revocation 
on the basis of the Iyer decision and the existence of prescriptions it 
filled ``in which there is no problem'' is unavailing for at least 
three reasons. First, as a threshold matter, I have already found that 
the scope of Trinity II's violations of federal law--particularly 
regarding Trinity II's egregious violations of its corresponding 
responsibility--far exceed the number that even the CALJ identified. In 
other words, some of the very prescriptions that Trinity II filled and 
claims in its Exceptions were ``no problem,'' were, in fact, highly 
problematic and illegal. Second, Trinity II's arguments based on the 
unpublished 11th Circuit opinion Iyer v. DEA are identical to those 
already rejected by the Agency in multiple final opinions, such as 
Wesley Pope, T.J. McNichol, and Dewey C. MacKay, and I incorporate the 
relevant portions of those final opinions herein. E.g., Wesley Pope, 82 
FR 14944, 14981-14984 (2017); T.J. McNichol, 77 FR 57133, 57144-57146 
(2012); Dewey C. MacKay, 75 FR at 49977. As I have pointed out 
previously (and repeat here for emphasis), the 11th Circuit has never 
chosen to publish the Iyer decision, and by local rule it is therefore 
not binding precedent for this case or for any other case. 11th Cir. R. 
36-2 (``Unpublished opinions are not considered binding precedent''). 
In addition, no subsequent 11th Circuit panel has chosen to adopt it; 
on the contrary, they have affirmatively declined multiple 
opportunities to do so. See Pope, 82 FR at 14983 (identifying cases in 
which respondents have raised Iyer-based arguments identical to Trinity 
II's, and the 11th Circuit has nonetheless denied the petitions of 
review and affirmed the Agency's sanction). Moreover, the 10th Circuit, 
in a published opinion, flatly rejected the same argument Trinity II 
has made here. MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011). 
Third, and most significantly, even assuming arguendo that Trinity II 
legally filled every other controlled substance prescription presented 
to it between February 2012 and February 2014, and I consider them 
consistent with Iyer, I nevertheless find that the violations 
identified by the CALJ are sufficiently egregious to outweigh the 
remaining (and presumptively non-problematic) prescriptions. Thus, I 
find that the CALJ did not err in his recommendation that revoking 
Trinity II's registration is in the public interest.
    I therefore hold that the Government has established its prima 
facie case that Trinity II's registration ``would be inconsistent with 
the public interest.'' 21 U.S.C. 823(f).

Sanction

    Where, as here, ``the Government has proved that a registrant has 
committed acts inconsistent with the public interest, a registrant must 
` ``present sufficient mitigating evidence to assure the Administrator 
that it can be entrusted with the responsibility carried by such a 
registration.'' ' '' Medicine Shoppe-Jonesborough, 73 FR 364, 387 
(2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting 
Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover, because `past 
performance is the best predictor of future performance,' ALRA Labs, 
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held 
that where a registrant has committed acts inconsistent with the public 
interest, the registrant must accept responsibility for its actions and 
demonstrate that it will not engage in future misconduct.'' Medicine 
Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. 
Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 
62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (``admitting 
fault'' is ``properly consider[ed]'' by DEA to be an ``important 
factor[ ]'' in the public interest determination).
    The Agency has also held that `` `[n]either Jackson, nor any other 
agency decision, holds . . . that the Agency cannot consider the 
deterrent value of a sanction in deciding whether a registration should 
be [suspended or] revoked.' '' Gaudio, 74 FR at 10094 (quoting 
Southwood, 72 FR at 36504); see also Robert Raymond Reppy, 76 FR 61154, 
61158 (2011); Moore, 76 FR at 45868. This is so, both with respect to 
the respondent in a particular case and the community of registrants. 
See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. 
McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's 
express adoptions of ``deterrence, both specific and general, as a 
component in analyzing the remedial efficacy of sanctions'').
    Here, the CALJ recommended that I find that Trinity II ``has not 
accepted responsibility'' and that, as a result, ``evidence of remedial 
steps is irrelevant.'' R.D. at 52 (citing Hassman, 75 FR at 8236). The 
CALJ further recommended that I find that, ``[i]n any event, the 
Respondent provided no evidence of remedial steps in this case.'' Id.
    In its Exceptions, Trinity II claims that the CALJ ``failed to 
provide

[[Page 7336]]

Respondents' with the opportunity to present their evidence'' ``that it 
accepts responsibility for the established misconduct, and has taken 
appropriate steps to prevent such misconduct in the future.'' Resp. 
Except. at 4. Trinity II specifically claims that the CALJ did not 
consider as ``mitigating evidence'' that Trinity II allegedly 
``voluntarily ceased dispensing schedule II controlled substances by 
March 1, 2014.'' Id. at 4-5.
    I agree with the CALJ that Trinity II has not accepted 
responsibility for its misconduct nor presented sufficient mitigating 
evidence to assure me that Trinity II can be entrusted with the 
responsibility carried by a DEA registration. The CALJ observed:

    There was no aspect of the evidentiary rulings issued during the 
prehearing proceedings in this case that would have limited [Trinity 
II's] ability to do so in any way. . . . the Respondent elected to 
proceed on a peculiar course where it presented no defense to these 
allegations, accepted no responsibility for them, and never 
indicated that it would act differently in the future. The 
registrant is essentially saying, it did it, it liked it, and it 
will continue to do it. . . . it has left the Agency little choice 
but to revoke its registration to ensure the safety of the public.

R.D. at 54 n.124. Indeed, even in its Exceptions, Trinity II identifies 
no evidence of acceptance of responsibility, much less remorse, for its 
misconduct in this case. It did not even try to provide such evidence 
at the hearing. And it is difficult to overstate the significance of 
the misconduct that Trinity II has failed to accept. Trinity II's 
willingness to knowingly fill seemingly any prescription and any 
combination of prescriptions that its customers presented--no matter 
how obvious it was that the prescription lacked a legitimate purpose--
is alarming. Trinity II was apparently equally ready to provide 
controlled substances to an unscrupulous customer earlier, or at 
dramatically greater dosages, than the prescribing physician had 
instructed on the face of the prescriptions.
    I thus find that Trinity II has not adequately accepted 
responsibility for its misconduct. This finding provides reason alone 
to conclude that Respondent has not rebutted the Government's prima 
facie showing that it has committed acts which render its continued 
registration ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). And having found that Trinity II knowingly diverted 
controlled substances, there is no need to consider its remedial 
efforts \86\ as they are rendered irrelevant by its failure to 
acknowledge its misconduct. See The Medicine Shoppe, 79 FR 59504, 59510 
(2014), pet. for rev. denied 626 Fed. Appx. 2 (Mem.) (D.C. Cir. 2015); 
Jayam Krishna-Iyer, 74 FR 459, 464 (2009) (``Because of the grave and 
increasing harm to public health and safety caused by the diversion of 
prescription controlled substances, even where the Agency's proof 
establishes that a practitioner has committed only a few acts of 
diversion, this Agency will not grant or continue the practitioner's 
registration unless he accepts responsibility for his misconduct.''). 
As the Tenth Circuit has recognized in the context of physician 
practitioners:
---------------------------------------------------------------------------

    \86\ Furthermore, the CALJ did not deny Trinity II, as it claims 
in its Exceptions, the opportunity to establish that it ceased 
dispensing schedule II controlled substances. Resp. Except. at 4-5. 
During the hearing, one of the DIs testified to his awareness that 
Trinity II stopped distributing schedule II controlled substances as 
of March 1, 2014. Tr. 527. However, Trinity II provided no evidence 
that this decision was intended to be remedial. More importantly, I 
have found that Trinity II's violation of its corresponding 
responsibility extended to other controlled substances, such as 
alprazolam, not regulated under schedule II. Thus, even if Trinity 
II had ceased distributing schedule II controlled substances as a 
remedial measure, it falls far short of what would have been 
necessary to mitigate Trinity II's misconduct.

    The DEA may properly consider whether a physician admits fault 
in determining if the physician's registration should be revoked. 
When faced with evidence that a doctor has a history of distributing 
controlled substances unlawfully, it is reasonable for the [DEA] to 
consider whether that doctor will change his or her behavior in the 
future. And that consideration is vital to whether continued 
---------------------------------------------------------------------------
registration is in the public interest.

MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (citing Hoxie v. DEA, 
419 F.3d at 483 (6th Cir. 2005)). See also Hoxie, 419 F.3d at 483 
(``The DEA properly considers the candor of the physician . . . and 
admitting fault [to be] important factors in determining whether the 
physician's registration should be revoked.'').
    I further find that the misconduct proven on this record is 
egregious and supports the revocation of Respondent's registration. 
More specifically, my finding that Trinity II's pharmacists dispensed 
multiple prescriptions in violation of their corresponding 
responsibility and thereby knowingly diverted controlled substances is, 
by itself, sufficient to support the revocation of its registration. 
Revocation is also warranted by my finding that, even with respect to 
valid prescriptions, Trinity II's pharmacists repeatedly and knowingly 
failed to fill them consistent with the prescribing physicians' 
instructions. Cf. Medicine Shoppe-Jonesborough, 300 Fed. Appx. 409, 
411-412 (6th Cir. 2008) (rejecting `` `human error' defense'' to 
dispensing ``the same drug in different concentrations'' because 
``dispensing the right drug in the wrong strength `can have serious 
consequences for the health of patients' '') (internal citations 
omitted).
    I further find that the Agency's interest in deterring future 
misconduct both on the part of Trinity II as well as the community of 
pharmacy registrants supports revocation. As for the issue of specific 
deterrence, the revocation of Trinity II's registration is not a 
permanent bar. And regarding general deterrence, those members of the 
regulated community who contemplate using their registrations to divert 
controlled substances need to know that there will be serious 
consequences if they choose to do so. This interest would be compelling 
even if it was not the case that the nation faces an epidemic of opioid 
abuse.
    I therefore conclude that the revocation of Trinity II's 
registration is necessary to protect the public interest. And I will 
further order that any application of Trinity II to renew or modify its 
registration, or for any other registration, be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration FT0531586 issued to Trinity Pharmacy II, Inc., be, and it 
hereby is, revoked. I further order that any application of Trinity 
Pharmacy II, Inc. to renew or modify its registration, or for any other 
registration, be, and it hereby is, denied. This order is effective 
immediately.

    Dated: February 6, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-03294 Filed 2-16-18; 8:45 am]
BILLING CODE 4410-09-P